Guidant Corp.
Medical device manufacturer in St Paul, MN.
86510(k) clearances
3PMA approvals
2recalls
Device types
- DQX Wire, Guide, Catheter 27
- FGE Stents, Drains And Dilators For The Biliary… 20
- DQY Catheter, Percutaneous 14
- LIT Catheter, Angioplasty, Peripheral… 4
- DTL Adaptor, Stopcock, Manifold, Fitting… 4
- NTE Temporary Carotid Catheter For Embolic… 4
- DRB Stylet, Catheter 3
- GCJ Laparoscope, General & Plastic Surgery 3
- GEI Electrosurgical, Cutting & Coagulation &… 2
- DQO Catheter, Intravascular, Diagnostic 1
- DXC Clamp, Vascular 1
- DTZ Oxygenator, Cardiopulmonary Bypass 1
- DTD Pacemaker Lead Adaptor 1
- NEY System, Ablation, Microwave And Accessories 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K061865 | Flex 10 Mis Ablation Probe, Model FLX10MI-05NEY · Special | 07/27/2006SE |
| K061453 | Hi-Torque Whisper View Guide WireDQX · Special | 06/22/2006SE |
| K060449 | Hi-Torque Advance and Advance Lite Guide WireDQX · Traditional | 05/30/2006SE |
| K053459 | Omnilink .035 Biliary Stent SystemFGE · Traditional | 04/12/2006SESU |
| K053454 | RX Herculink Elite Biliary Stent SystemFGE · Traditional | 03/06/2006SESU |
| K053019 | Acuity Steerable Stylet AccessoryDRB · Traditional | 03/03/2006SE |
| K052965 | Easytrak 2 Stylet, Models 4826, 4829, 4832.DRB · Traditional | 02/13/2006SE |
| K052274 | Guidant Vasoview Hemopro Endoscopic Vessel Harvesting System, Model VH-3000GEI · Special | 09/21/2005SE |
| K052166 | Modification to: RX Accunet Embolic Protection SystemNTE · Special | 08/18/2005SE |
| K052165 | RX Accunet Embolic Protection SystemNTE · Special | 08/16/2005SE |
| K042908 | RX Accunet 2 Embolic Protection SystemNTE · Special | 11/12/2004SE |
| K042218 | Accunet Embolic Protection System, RX Accunet Embolic Protection SystemNTE · Traditional | 08/31/2004SE |
| K041981 | Guidant Vasoview 6 Harvesting Cannula, Model VH-2000; Guidant Vasoview 6 Accessory Pack…GEI · Special | 08/20/2004SE |
| K041762 | Finishing Wire SupportrakDQX · Traditional | 08/06/2004SE |
| K041574 | Cpi Lead Adapters, Models 6017, 6018 and 6020DTD · Special | 07/12/2004SE |
| K031903 | Rapido Cut-Away Bleedback Control Valve (BBCV), Model 7568DTZ · Traditional | 03/03/2004SE |
| K033834 | Omnilink .018 Biliary Stent SystemFGE · Special | 01/02/2004SESU |
| K033393 | Absolute .035 Self-Expanding Biliary Stent SystemFGE · Special | 11/10/2003SESU |
| K032530 | Modification to Omnilink .035 Biliary Stent SystemFGE · Special | 10/23/2003SESU |
| K031678 | Hi-Torque Balance Iniversal Guide Wire with Hydrocoat Hydrophilic CoatingDQX · Traditional | 08/26/2003SE |
| K031459 | Rapido Cut-Away CutterDQY · Traditional | 07/23/2003SE |
| K031688 | Rapido Cut-A-Way Rotating Hemostasis ValveDTL · Special | 07/02/2003SE |
| K031505 | Rapido Cut-Away Guiding CatheterDQY · Special | 06/25/2003SE |
| K031398 | IS-1 Hemostasis Valve, Model 6799DTL · Special | 05/20/2003SE |
| K030512 | Guidant Vasoview Endoscopic Vessel Harvesting SystemGCJ · Traditional | 05/14/2003SE |
| K030019 | Modification to Hi-Torque Whisper GuidewireDQX · Special | 01/24/2003SE |
| K023320 | Agiltrac .035 Peripheral Dilatation CatheterDQY · Traditional | 12/10/2002SE |
| K023627 | Essex Endoscope, Model SXD-1000GCJ · Traditional | 11/12/2002SE |
| K023300 | Hi-Torque Whisper LS; Hi-Torque Whisper MS; Hi-Torque Whisper MS Cs-J; Hi-Torque Whisper…DQX · Special | 10/28/2002SE |
| K022880 | Guidant Proximal Seal System, Models PSS-4500 & PS-4500DXC · Traditional | 09/13/2002SE |
| K022738 | Agiltrac .035 Peripheral Dilatation CatheterDQY · Special | 09/13/2002SE |
| K021455 | Rapido Guiding Catheter, 6F Model# 6776; Rapido Guiding Catheter, 8F Model# 6775, 6777…DQY · Traditional | 08/02/2002SE |
| K021824 | Dynalink .035 Biliary Self-Expanding Stent System, Models…FGE · Special | 07/02/2002SESU |
| K021228 | Hi-Torque Balance, Balance Middleweight, Balance Heavyweight, Balance Trek and the…DQX · Special | 05/15/2002SE |
| K021285 | Hi-Torque Extra S'Port GuidewireDQX · Traditional | 05/02/2002SE |
| K021284 | Easytrak Guiding CatheterDQY · Traditional | 05/02/2002SE |
| K021283 | Guidant Balloon Catheter, Several ModelsDQO · Traditional | 05/02/2002SE |
| K021282 | LV-1 Hemostasis Valve, Model #6789DTL · Traditional | 05/02/2002SE |
| K020340 | Modification to Hi-Torque Whisper LS and MS Guide Wires with Hydrocoat Hydrophilic CoatingDQX · Special | 03/01/2002SE |
| K020161 | Agiltrac .018 Peripheral Dilatation CatheterDQY · Special | 02/22/2002SE |
| K014184 | Modification to Dynalink .035 Biliary Self-Expanding Stent SystemFGE · Special | 01/18/2002SESU |
| K013833 | Hi-Toque Balance Middleweight Universal Guide Wire with Hydrocoat Hydrophilic Coating…DQX · Traditional | 01/16/2002SE |
| K014250 | 7MM Extended Length Endoscope,Dissection Tips, Models VH-1111, VH-1114GCJ · Traditional | 01/10/2002SE |
| K014007 | Dynalink .018 Billary Self-Expanding Stent SystemFGE · Special | 01/07/2002SESU |
| K013092 | Hi-Toque Whisper LS and MS Guide Wire with Hydrocoat Hydrophilic CoatingDQX · Traditional | 12/13/2001SE |
| K013638 | Modification to Viking Optima Guiding CatheterDQY · Special | 12/04/2001SE |
| K012050 | Viatrac 14 Plus Peripheral Dilatation CatheterDQY · Special | 09/06/2001SE |
| K012002 | Viking Optima Guiding CatheterDQY · Special | 07/26/2001SE |
| K011881 | Dynalink .035 Biliary Self-Expanding Stent SystemFGE · Special | 07/18/2001SESU |
| K011506 | Omnilink .035 Biliary Stent SystemFGE · Special | 06/15/2001SESU |
| K010831 | Aviator Peripheral Dilatation CatheterDQY · Special | 06/13/2001SE |
| K011039 | Omnilink .018 Biliary Stent SystemFGE · Special | 05/08/2001SESU |
| K010684 | RX Herculink Plus Biliary Stent SystemFGE · Special | 04/12/2001SESU |
| K002143 | Dynalink Biliary Self-Expanding Stent SystemFGE · Traditional | 10/12/2000SESU |
| K002206 | Hi-Torque Whisper LS Guide Wire with Hydrocoat Hydrophilic Coating, Hi-Torque Whisper MS…DQX · Traditional | 08/24/2000SE |
| K001435 | Viking Optima Guiding CatheterDQY · Special | 06/02/2000SE |
| K001224 | RX Herculink 14 Biliary Stent System, Models 1005127-13, 1005129-13, 1005131-13…FGE · Special | 05/17/2000SESU |
| K001222 | Otw Megalink SDS Billiary Stent System, Models 1005509-18, 1005510-18, 1005511-18…FGE · Special | 05/17/2000SESU |
| K000793 | 1 Otw Viatrac 18 Peripheral Dilatation CatheterFGE · Special | 04/12/2000SE |
| K000598 | 5F Guiding CatheterDQY · Special | 03/24/2000SE |
| K000101 | RX Viatrac 14 Peripheral Dilatation CatheterLIT · Special | 02/10/2000SE |
| K993639 | RX Viatrac 18 Peripheral Dilatation Catheter, Otw Viatrac 18 Peripheral Dilatation…LIT · Traditional | 01/27/2000SE |
| K993588 | Modification to RX Herculink 14 Biliary Stent System, Models 1005126-13, 1005128-13…FGE · Special | 11/17/1999SE |
| K992863 | Lead Stylet,Models 6505,6506,6507,6508DRB · Traditional | 11/12/1999SE |
| K992319 | RX Megalink SDS Biliary Stent System, Otw Megalink SDS Biliary Stent SystemFGE · Traditional | 10/08/1999SESU |
| K991102 | Copilot Bleedback Control Valve, Model 1003331DTL · Traditional | 06/09/1999SE |
| K991032 | Guidant Megalink Biliary Stent, Model FG1002949-58FGE · Special | 04/30/1999SESU |
| K991152 | Hi-Torque Balance Trek Guide WireDQX · Special | 04/29/1999SE |
| K990639 | Acs Hi-Torque Cross It 100XT, 200XT and 300XT Guide Wires with Hydrocoat Hydrophilic…DQX · Special | 03/25/1999SE |
| K983346 | Standard 0.025 Straight, Standard 0.025 Angled, Standard 0.032 Straight, Standard 0.032…DQX · Traditional | 03/23/1999SE |
| K984394 | Acs Hi-Torque Wiggle Guide Wire with Microglide CoatingDQX · Traditional | 03/08/1999SE |
| K983075 | Guidant Megalink Biliary Stent, Model #'S 1002949-18, 1002949-28, 1002949-38FGE · Traditional | 03/03/1999SESU |
| K983055 | RX Viatrac 14 Peripheral Dilatation Catheter, Model #'S 1003006-20, 1003007-20…LIT · Traditional | 12/30/1998SE |
| K983033 | Acs HT Balance Middleweight Guide WireDQX · Traditional | 11/10/1998SE |
| K982876 | Hi-Torque Steelcore 18 Guide Wire Model Numbers 1003280, 1003281, 1003282DQX · Traditional | 11/10/1998SE |
| K982083 | Acs Hi-Torque Balance Heavyweight Guide Wire with Hydrocoat Hydrophilic CoatingDQX · Traditional | 09/11/1998SE |
| K981381 | Acs Hi-Torque Cross-It Guide Wire with Hydrocoat Hydrophilic Coating Product Family…DQX · Traditional | 07/15/1998SE |
| K980294 | Acs Hi-Torque Super Sport Guide Wire with Hydrocoat Hydrophilic CoatingDQX · Traditional | 04/24/1998SE |
| K980119 | Acs Hi-Torque Wholey Supra Core Guide WireDQX · Traditional | 03/20/1998SE |
| K974773 | Hi-Torque Floppy Guide Wire with Hydrocoat Hydrophilic Coating, Hi-Torque Standard Guide…DQX · Traditional | 03/13/1998SE |
| K973494 | Hi-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs Hi-Torque Balance…DQX · Traditional | 12/12/1997SE |
| K972484 | Acs Viking Guiding CatheterDQY · Traditional | 09/26/1997SE |
| K972290 | Acs Hi-Torque Ruler Guide WireDQX · Traditional | 09/17/1997SE |
| K972142 | Acs Hi-Torque All Star 0.014 Guide Wire with Microglide CoatingDQX · Traditional | 08/25/1997SE |
| K971815 | Asc Balance Middleweight Guide WireDQX · Traditional | 07/09/1997SE |
| K965183 | Vantage Peripheral Dilatation CatheterLIT · Traditional | 04/24/1997SE |
PMA approvals
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0269-2007 | Guidant CONTAK RENEWAL 3 RF (models H210, H215), CONTAK RENEWAL 3 RF HE (models H217…Shock Effectiveness: there is a potential for malfunction of a high voltage wire, which could compromise… | 09/30/2006Terminated |
| Z-0002-2007 | Guidant Zoom Latitude Programming System, Model 3120, Programmer/Recorder/Monitor (PRM).…Final software load did not occur prior to shipment of select programmers. | 05/19/2006Terminated |