Biotronik, Inc.
Medical device manufacturer in Lake Oswego, OR.
104510(k) clearances
11PMA approvals
27recalls
Device types
- DTB Permanent Pacemaker Electrode 26
- DQY Catheter, Percutaneous 23
- MXD Recorder, Event, Implantable Cardiac, (With… 11
- LIT Catheter, Angioplasty, Peripheral… 10
- DXY Implantable Pacemaker Pulse-Generator 9
- DTD Pacemaker Lead Adaptor 6
- DQX Wire, Guide, Catheter 5
- DTA Tester, Pacemaker Electrode Function 3
- LOX Catheters, Transluminal Coronary… 3
- DTC Analyzer, Pacemaker Generator Function 2
- DTE Pulse-Generator, Pacemaker, External 2
- KRE Analyzer, Pacemaker Generator Function… 1
- DPS Electrocardiograph 1
- DRB Stylet, Catheter 1
- DRF Catheter, Electrode Recording, Or Probe… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K261074 | Biomonitor IV (471155)MXD · Special | 05/01/2026SE |
| K250706 | Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters…LIT · Special | 04/04/2025SE |
| K242969 | Pantera Pro; Pantera LEOLOX · Special | 10/25/2024SE |
| K240787 | Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool…DQY · Traditional | 09/12/2024SE |
| K241711 | Oscar Peripheral Multifunctional Catheter systemLIT · Special | 07/11/2024SE |
| K230375 | Biomonitor IVMXD · Traditional | 05/19/2023SE |
| K222065 | Passeo-35 Xeo Peripheral Dilatation CatheterLIT · Traditional | 02/16/2023SE |
| K221856 | BIOMONITOR IIIm, BIOMONITOR IIIMXD · Special | 07/27/2022SE |
| K222037 | Selectra Lead Implantation SystemDQY · Special | 07/19/2022SE |
| K214038 | Oscar Peripheral Multifunctional Catheter systemLIT · Traditional | 07/06/2022SE |
| K201445 | MultiCath, AcQRate Dx Fixed Curve CatheterDRF · Traditional | 09/02/2021SE |
| K201865 | Biomonitor III, Biomonitor IIImMXD · Traditional | 12/08/2020SE |
| K193474 | Selectra 3D Outer Guiding CathetersDQY · Traditional | 10/16/2020SE |
| K200444 | Biomonitor III, Biomonitor IIImMXD · Traditional | 04/23/2020SE |
| K192996 | Selectra Catheters, Selectra Accessory Kit, Selectra Slitter ToolDQY · Special | 11/21/2019SE |
| K191469 | Biotronik StyletsDRB · Traditional | 08/01/2019SE |
| K190548 | BIOMONITOR III, Remote Assistant IIIMXD · Traditional | 07/05/2019SE |
| K183265 | Selectra Catheters, Selectra Accessory KitDQY · Special | 12/13/2018SE |
| K171514 | BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, SetMXD · Special | 06/29/2017SE |
| K170628 | BioMonitor 2-AF, BioMonitor 2-SMXD · Special | 03/31/2017SE |
| K163660 | Pantera LEOLOX · Special | 01/26/2017SE |
| K160985 | Pantera ProLOX · Traditional | 10/07/2016SE |
| K152995 | BioMonitor 2-AF, BioMonitor 2-SMXD · Traditional | 04/11/2016SE |
| K152240 | Passeo-14 Peripheral Dilatation CatheterLIT · Traditional | 10/08/2015SE |
| K151744 | Passeo-18 Peripheral Dilation CatheterLIT · Special | 10/08/2015SE |
| K151409 | Selectra Catheters and Selectra Accessory KitDQY · Special | 08/07/2015SESK |
| K143503 | BioMonitorMXD · Traditional | 03/19/2015SE |
| K142379 | Passeo-35 PTA CatheterLIT · Special | 12/05/2014SE |
| K132960 | BiomonitorMXD · Traditional | 06/06/2014SE |
| K131978 | Selectra Accessory Kit, Selectra Slitter ToolDQY · Special | 08/23/2013SE |
| K130161 | PASSEO-35LIT · Traditional | 04/23/2013SE |
| K123324 | Selectra 7F CathetersDQY · Special | 01/11/2013SE |
| K112482 | Selectra Slitter ToolDQY · Special | 09/26/2011SE |
| K111839 | Selectra Accessory KitDQY · Traditional | 09/26/2011SE |
| K111154 | Selectra IC-50-60, Selectra IC-50-75, Selectra IC-90-65, Selectra IC-90-75DQY · Special | 05/23/2011SE |
| K110461 | Selectra CS Lead Introducer SystemDQY · Special | 04/20/2011SE |
| K101776 | Scoutpro AcsDQY · Special | 07/23/2010SE |
| K101282 | Scoutpro Hemostatic ValveDQY · Special | 07/21/2010SE |
| K093303 | Scoutpro 7F Long CathetersDQY · Special | 11/20/2009SE |
| K083674 | PK-141 Patient CableDTC · Traditional | 04/01/2009SE |
| K082935 | Vision Wire Coronary GuidewireDQX · Traditional | 12/04/2008SE |
| K082933 | PASSEO-35 Pta CatheterDQY · Special | 11/03/2008SE |
| K080988 | Scoutpro CS Lead Introducer SystemDQY · Special | 05/07/2008SE |
| K072329 | Scoutpro 8F, 7F and Slitter Tool AdvancedDQY · Special | 03/25/2008SE |
| K073230 | Models Era 300 and 3105 Pacing System AnalyzersDTA · Special | 12/20/2007SE |
| K072765 | Passeo 18LIT · Special | 12/12/2007SE |
| K071665 | Scoutpro Slitter Tool Advanced, Model 356 552DQY · Special | 07/18/2007SE |
| K061212 | Biotronik Endocardial Pacing LeadsDTB · Special | 07/10/2006SE |
| K060807 | Scoutpro 7F Coronary Sinus Lead Delivery SystemDQY · Special | 04/24/2006SE |
| K060655 | Scoutpro 8F, Models 342 262; Hemostatic Valve, Models 345 968; Hook Guiding Catheter…DQY · Special | 04/04/2006SE |
| K052757 | Pheron Peripheral Percutaneous Transluminal Angioplasty (Pta) CatheterLIT · Special | 10/28/2005SE |
| K042373 | Galeo Focus Guide WireDQX · Traditional | 03/02/2005SE |
| K042708 | Era 3000 Pacing System AnalyzerDTE · Special | 10/20/2004SE |
| K033613 | Modification to Era 300 Dual Chamber Pacing System AnalyzerDTA · Special | 12/08/2003SE |
| K033320 | Scout ProDQY · Special | 11/19/2003SE |
| K033217 | Pheron Pta CatheterDQY · Traditional | 10/31/2003SE |
| K023205 | Elox P 45-BP; Elox P 53-BP; Elox P 60-BPDTB · Traditional | 04/24/2003ST |
| K022360 | Era 3000; PA-2 IS-1 Adapter; EK-4-N Pacemaker Test Cable; Era 3000 Charger; Era 3000…DTA · Traditional | 01/27/2003SE |
| K023803 | Modification to Biotronik's Sterilization ProcessDTB · Special | 12/11/2002SE |
| K023099 | Arox 45-JBP; Arox 53-JBP; Merox 45-JBP; Merox 53-JBPDTB · Special | 10/18/2002SE |
| K020821 | Scout (Sinus Cornarius Utility Tool), Model 335 117DQX · Traditional | 06/03/2002SE |
| K021217 | Arox 53-BP; Arox 60-BP; Arox 45-JBP; Arox 53-JBPDTB · Special | 05/01/2002SE |
| K010281 | Merox Bipolar High Impedance Lead Models: Mex 53/13-BP; 60/15-BP; 45-JBP; 53-JBPDTB · Traditional | 04/09/2002SE |
| K003454 | A1-CS-SB Y-Adapter, Model 124 871DTD · Special | 01/18/2001ST |
| K003072 | Pacing Leads, Guide Wires, and Various AccessoriesDTB · Traditional | 01/09/2001SE |
| K001736 | Galeo Hydro and Galeo Hydro J-TipDQX · Special | 08/02/2000SE |
| K001413 | Elox 45-BP, Model 330 132, EFH-27, Model 331 549, Extension Tool, Model 331 668DTB · Special | 06/02/2000ST |
| K994240 | Ex 45-BP, Model 330 132; Ex 53-BP, Model 130 018; Ex 60-BP, Model 330 133DTB · Traditional | 04/13/2000ST |
| K000763 | PX 53/15-BP, Model 130 050 and PX 60/15-BP, Model 130 051DTB · Special | 04/06/2000ST |
| K993139 | Yp 45/15-BP; Yp 53/15-BP; Yp 60/15-BPDTB · Traditional | 12/17/1999ST |
| K993434 | Pikos 01, Pikos E01, Pikos 01-B, Pikos E01-B, Pikos 01-A, Pikos E01-ADXY · Special | 11/10/1999SE |
| K991169 | SX 53/15-BP, Model 124 853, SX 60/15-BP, Model 124 854DTB · Traditional | 07/01/1999ST |
| K990483 | Retrox RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777DTB · Traditional | 06/03/1999ST |
| K982272 | Galeo HS 014 Model 117 130, Galeo S 014 Model 115 488, Galeao M 014 Model 114156, Galeo…DQX · Traditional | 01/08/1999SE |
| K980869 | Synox SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , Models 120 444, 119 684, 120 438 and…DTB · Traditional | 09/10/1998SE |
| K981083 | Retrox RX 53-BP, Retrox RX 60-BP, Retrox RX 45-JBP, Retrox RX 53-JBP Model Numbers 124…DTB · Traditional | 07/22/1998ST |
| K972500 | Tir/Tij and PolyroxDTB · Traditional | 03/04/1998PT |
| K965106 | Elc 35-UP Model Number 116015 and Elc 54-UP Model Number 115606DTB · Traditional | 01/27/1998PT |
| K971930 | Bk-N Sealing CapDTD · Traditional | 08/14/1997PT |
| K970388 | A1-A,ABP,B,MBP, Lead Connectors; Peh Adapter SleeveDTD · Traditional | 08/14/1997PT |
| K964190 | Era 300 Dual Chamber Pacing System AnalyzerDTE · Traditional | 07/10/1997SE |
| K970204 | Bk-A; Bk-B; Bk-Is Sealing CapDTD · Traditional | 04/29/1997SE |
| K964604 | Bipolar Implantable Endocardial Pacing Leads, with Silicone Rubber Insulation and…DTB · Traditional | 03/10/1997PT |
| K953044 | Unipolar & Bioplar Implantable Endocardial Pacing Leads, with Silicone Rubber Insulation…DTB · Traditional | 09/27/1996PT |
| K945627 | Pikos LP 01, Pikos LP E01DXY · Traditional | 03/04/1996SESP |
| K952328 | Nanos, Pikos 01/E01, 01-A, E01-B, LP 01/LP E01DXY · Traditional | 09/29/1995ST |
| K941937 | Pikos E 01-BDXY · Traditional | 08/30/1994SESP |
| K923406 | BioscopeDPS · Traditional | 09/22/1993SE |
| K923026 | Pikos 01-A and Pikos E01-A Implantable PacemakerDXY · Traditional | 08/19/1993SE |
| K922742 | HPM 40 Heart Pacemaker MonitorKRE · Traditional | 03/18/1993SE |
| K914109 | Pikos 01 & Pikos E 01DXY · Traditional | 02/26/1992SE |
| K910609 | Permanent Implantable JP Endocardial Leads W/TipDTB · Traditional | 08/28/1991SE |
| K911142 | Lead Terminal Pin Caps, Various ModelsDTD · Traditional | 08/09/1991SE |
| K910608 | Permanent Implantable FH Endocardial Leads W/TipDTB · Traditional | 07/30/1991SE |
| K905087 | Trios 02DXY · Traditional | 05/07/1991SE |
| K903929 | Label Change Unipolar Endocardial Lead, DJP 60-UPDTB · Traditional | 10/16/1990SE |
| K903928 | Label Change Unipolar Endocardial Lead DJP 53-UPDTB · Traditional | 10/16/1990SE |
| K903927 | Label Change Unipolar Endocardial Lead, DJP 45-UPDTB · Traditional | 10/16/1990SE |
| K903081 | Neos (TM) 02 B Pulse GeneratorDXY · Traditional | 09/14/1990SE |
| K902889 | A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH Pace.DTD · Traditional | 08/23/1990SE |
| K896824 | Biotronik's Ps-Endocardial LeadsDTB · Traditional | 08/08/1990SE |
| K901709 | DNP 60-B Unipolar Endocardial LeadDTB · Traditional | 05/22/1990SE |
| K901332 | PK-55 Andover Medical Part #5455 Label ChangeDTC · Traditional | 05/09/1990SE |
| K894494 | Labeling Changes to Pulse Gene. & Pulse Gene. LeadDXY · Traditional | 10/17/1989SE |
PMA approvals
- P170030 ORSIRO Sirolimus Eluting Coronary Stent System · 02/22/2019 · 62 supplements
- P160025 Astron Pulsar Stent System, PULSAR-18 Stent System · 03/23/2017 · 25 supplements
- P160003 PRO-KINETIC ENERGY COBALT CHROMIUM (CoCr) CORONARY STENT SYSTEM · 02/14/2017 · 25 supplements
- P140030 Astron Peripheral Self-Expanding Nitinol Stent System · 12/17/2015 · 24 supplements
- P070008 Stratos LV Crt-P and Stratos Lv-T Crt-P, Corox Otw BP Lead and Corox Otw-S BP Lead · 05/12/2008 · 170 supplements
- P050023 Tupos Lv/Atx & Kronos Lv-T Crt-D & Corox Owt Steroid LV Pacing Lead · 08/10/2006 · 202 supplements
- P030037 Rithron-Xr Coronary Stent System · 04/29/2005 · 0 supplements
- P000009 Phylax Av Icd System · 09/29/2000 · 121 supplements
- P980023 Phylax Implantable Cardioverter Defibrillator System · 10/27/1998 · 144 supplements
- P950037 Dromos Dr/Dr-A and Dromos Sr/Sr-B Cardiac Pacing Systems · 10/11/1996 · 276 supplements
- P820076 Diplos Model 05 a & B · 02/15/1984 · 28 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1465-2021 Class II | BIOTRONIK INTICA NEO 7 HF-T DF-1 IS-1 ProMRI, REF 429553, UDI: 04035479156831 - Product…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1464-2021 Class II | BIOTRONIK ILIVIA NEO 7 DR-T DF-1 ProMRI, REF 429529, UDI: 04035479156749 - Product…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1463-2021 Class II | BIOTRONIK INTICA NEO 7 VR-T DX DF-1 ProMRI, REF 429559, UDI: 04035479156855 - Product…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1462-2021 Class II | BIOTRONIK ILIVIA NEO 7 VR-T DF-1 ProMRI, REF 429531, UDI: 04035479156763 - Product…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1461-2021 Class II | BIOTRONIK ILIVIA 7, DR-T DF-1 PROMRI, REF 404622, UDI: 04035479142094 - Product Usage:…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1460-2021 Class II | BIOTRONIK INVENTRA 7, VR-T DX DF-1, REF 399437, UDI: 04035479136321 - Product Usage:…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1459-2021 Class II | BIOTRONIK INVENTRA 7, VR-T DX DF-1 ProMRI, REF 399436, UDI: 04035479136314 - Product…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1458-2021 Class II | BIOTRONIK ILIVIA 7, VR-T DF4 ProMRI, REF 404626, UDI: 04035479142131 - Product Usage:…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1457-2021 Class II | BIOTRONIK ILIVIA 7, VR-T DF-1 ProMRI, REF 404625, UDI: 04035479142124 - Product Usage:…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1456-2021 Class II | BIOTRONIK ILIVIA 7, DR-T DF4 ProMRI, REF 404623, UDI: 04035479142100 - Product Usage:…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1455-2021 Class II | BIOTRONIK ITREVIA 7, DR-T QP DF-1, REF 392412, UDI: 04035479128807 - Product Usage:…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1454-2021 Class II | BIOTRONIK INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - Product Usage:…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1453-2021 Class II | BIOTRONIK IPERIA 7, DR-T DF4 ProMRI, REF 392423, UDI: 04035479128913 - Product Usage:…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1452-2021 Class II | BIOTRONIK ITREVIA 7, VR-T DF-4, REF 393041, UDI: 04035479129569 - Product Usage:…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1451-2021 Class II | BIOTRONIK ITREVIA 7, VR-T DF-1, REF 393040, UDI: 04035479129552 - Product Usage:…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1450-2021 Class II | BIOTRONIK ITREVIA 7, VR-T DX DF-1, REF 393037, UDI: 04035479129521 - Product Usage:…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1449-2021 Class II | BIOTRONIK IPERIA 7,VR-T, DX, DF-1, ProMRI, REF 393032, UDI: 04035479129477 - Product…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1448-2021 Class II | BIOTRONIK Iforia 7,DR-T, DF-1,REF 390064, UDI: 04035479126926 - Product Usage: intended…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1447-2021 Class II | BIOTRONIK Iforia 7, vr-T, DX, DF-1,REF 390090, UDI: 04035479127176 - Product Usage:…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1446-2021 Class II | BIOTRONIK Iperia 7, DR-T, DF-1, ProMRI REF 392409, UDI: 04035479128777 - Product Usage:…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1445-2021 Class II | BIOTRONIK Ilestro 7 VR-T DX, DF-1, REF 383594, UDI: 04035479125509 - Product Usage:…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1444-2021 Class II | BIOTRONIK Ilestro 7 VR-T, DF-4, REF 383580, UDI: 04035479125363 - Product Usage:…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1443-2021 Class II | BIOTRONIK Ilestro 7 VR-T, DF-1, REF 383578, UDI: 04035479125349 - Product Usage:…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1442-2021 Class II | BIOTRONIK Ilestro 7 DR-T, DF-4, REF383564, UDI: 04035479125202 - Product Usage: intended…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-1441-2021 Class II | BIOTRONIK Ilestro 7 DR-T, DF-1, REF383562, UDI: 04035479125189 - Product Usage: intended…There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac… | 03/08/2021Terminated |
| Z-2376-2015 Class II | PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer…Ventricular packing: LV software programming versions for BIOTRONIK CRT-P and CRT-D devices are recalled… | 06/30/2015Terminated |
| Z-1373-2008 | Lumax Cardiac Resyncronization Therapy Defibrillator (CRT-D); Implantable, dual-chamber…Timing Feature Error: An implementation error allows the usage of the V-V timing feature, which is not… | 01/10/2007Terminated |