Transducer, Pressure, Catheter Tip
FDA product code DXO · Class II (moderate risk) · 21 CFR 870.2870 · Cardiovascular
64510(k) clearances
0PMA approvals
10recalls
Manufacturers
- Millar Instruments, Inc. 7
- Opsens, Inc. 6
- Camino Laboratories, Inc. 5
- Edwards Lifesciences, LLC 5
- Radi Medical Systems AB 4
- Boston Scientific Corporation 3
- Becton Dickinson Vascular Access, Inc. 2
- Baxter Healthcare Corp 2
- Endosonics Corp. 2
- Ppg Industries, Inc. 2
- Deseret Medical, Inc. 2
- St Jude Medical 2
- St. Jude Medical Systems AB 2
- Acist Medical Systems, Inc. 2
- Medical Data Electronics 1
- Draeger Medical, Inc. 1
- Zurich Medical, Inc. 1
- Gould, Inc. 1
- Carbomedics, Inc. 1
- American Bentley 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251367 | OptoMonitor 3DXO · Traditional | Opsens, Inc. | 01/16/2026SE |
| K241418 | OptoMonitor 3DXO · Traditional | Opsens, Inc. | 02/12/2025SE |
| K233904 | ACIST RXi System (016616); ACIST Navvus II Catheter (016675_DXO · Traditional | Acist Medical Systems, Inc. | 07/17/2024SE |
| K222216 | TruWave Disposable Pressure TransducerDXO · Traditional | Edwards Lifesciences, LLC | 12/22/2022SE |
| K202943 | OptoMonitor 3DXO · Traditional | Opsens, Inc. | 11/24/2020SE |
| K193620 | OptoMonitor 3DXO · Traditional | Opsens, Inc. | 06/18/2020SE |
| K193279 | Comet II Pressure GuidewireDXO · Special | Boston Scientific Corporation | 12/23/2019SE |
| K192340 | OptoMonitorDXO · Traditional | Opsens, Inc. | 12/12/2019SE |
| K190852 | Zurich Pressure Guidewire System Model 100DXO · Traditional | Zurich Medical, Inc. | 08/14/2019SE |
| K183413 | TruWave Disposable Pressure TransducerDXO · Traditional | Edwards Lifeciences, LLC | 05/01/2019SE |
| K180558 | PressureWire XDXO · Special | St. Jude Medical (Now Part of Abbott Medical) | 03/28/2018SE |
| K171996 | TruWave Disposable Pressure TransducerDXO · Traditional | Edwards Lifesciences, LLC | 10/23/2017SE |
| K163376 | Mikro-Cath Pressure CatheterDXO · Traditional | Millar, Inc. | 03/10/2017SE |
| K161263 | OptoMonitor IIDXO · Traditional | Opsens, Inc. | 09/13/2016SE |
| K161171 | PressureWire X GuidewireDXO · Traditional | St. Jude Medical, Inc. | 08/15/2016SE |
| K151610 | Comet Pressure GuidewireDXO · Traditional | Boston Scientific Corporation | 10/06/2015SE |
| K142749 | TruWave Disposable Pressure TransducerDXO · Traditional | Edwards Lifesciences, LLC | 01/18/2015SE |
| K140466 | Pressurewire: Aeris Agile Tip, Aeris Agile Tip 300, Certus Agile Tip, Certus Agile Tip 300DXO · Traditional | St. Jude Medical Systems AB | 11/13/2014SE |
| K141495 | Truwave Disposable Pressure TransducerDXO · Traditional | Edwards Lifesciences, LLC | 09/03/2014SE |
| K132474 | Cardiovascular Pressure Measurement (CPM) System, Navvus CatheterDXO · Traditional | Acist Medical Systems | 01/30/2014SE |
| K131452 | Pressurewire; Certus, Certus 300, Aeris, Aeris 300DXO · Traditional | St. Jude Medical Systems AB | 09/05/2013SE |
| K113584 | Pressurewire Certus, Certus 300, Aeris, Aeris 300, and ReceiverDXO · Traditional | St Jude Medical | 03/02/2012SE |
| K112323 | Cardia-CathDXO · Special | Millar Instruments, Inc. | 10/18/2011SE |
| K093111 | Mikro-Cath, Model 825-0101DXO · Abbreviated | Millar Instruments, Inc. | 01/05/2010SE |
| K080813 | Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), ReceiverDXO · Traditional | Radi Medical Systems AB | 07/01/2008SE |
| K070487 | Smartwire Pressure Guide Wire, Model 66XXDXO · Special | Volcano Corporation | 03/16/2007SE |
| K062769 | Pressurewire Certus, Models 12006 and 12306DXO · Special | Radi Medical Systems AB | 12/04/2006SE |
| K053016 | Wireless Physiologic Monitoring SystemDXO · Traditional | Edwards Lifesciences, LLC | 12/30/2005SE |
| K031662 | Pressure Wire Sensor, Models 12004/12304DXO · Special | Radi Medical Systems AB | 06/06/2003SE |
| K022187 | Pressure Wire Sensor, Models 12003/12303, 12004/12304DXO · Traditional | Radi Medical Systems AB | 09/24/2002SE |
| K935166 | Flow Directed Mikro-Tip Pressure TransducerDXO · Traditional | Millar Instruments, Inc. | 08/05/1994SE |
| K941283 | Innersense Disposable MicrotransducerDXO · Traditional | Becton Dickinson Vascular Access, Inc. | 04/19/1994SE |
| K925638 | Phoenix Disposable Pressure Transducer #73-600DXO · Traditional | Baxter Healthcare Corp | 10/18/1993SE |
| K924737 | Innersense(Tm) Disposable MicrotransducerDXO · Traditional | Becton Dickinson Vascular Access, Inc. | 08/23/1993SE |
| K920580 | Transducer, Pressure, Catheter TipDXO · Traditional | Medamicus, Inc. | 01/07/1993SE |
| K913042 | Modifications to Series of Cardiac CathetersDXO · Traditional | Sentron, Inc. | 10/21/1992SE |
| K915775 | Millar Nonmagnectic Mikro-Tip Catheter Press. TranDXO · Traditional | Millar Instruments, Inc. | 04/20/1992SE |
| K910429 | Swan-Ganz Flow Directed Pressure TD CatheterDXO · Traditional | Baxter Healthcare Corp | 07/11/1991SE |
| K895721 | Millar Mikro-Tip Pulse TransducerDXO · Traditional | Millar Instruments, Inc. | 12/07/1989SE |
| K894033 | Disposable Catheter Pressure TransducerDXO · Traditional | Deseret Medical, Inc. | 10/17/1989SE |
| K894747 | Precept-Gt(Tm) Microsensor Pressure Monitor Cath.DXO · Traditional | Endosonics Corp. | 10/12/1989SE |
| K894286 | PPG Biomedical Flexible Micro Transducer CatheterDXO · Traditional | Ppg Industries, Inc. | 10/12/1989SE |
| K890492 | Precept-Pt(Tm) Microsensor Pressure Monitor Cath.DXO · Traditional | Endosonics Corp. | 03/02/1989SE |
| K883202 | Ultrasonic Imaging CatheterDXO · Traditional | Boston Scientific Corp | 11/23/1988SE |
| K883436 | PPG Biomedical Flexible Micro Transducer CatheterDXO · Traditional | Ppg Industries, Inc. | 10/17/1988SE |
| K880830 | Sentorr Arterial Pressure SensorDXO · Traditional | Ohmeda Medical | 08/12/1988SE |
| K882031 | Vitalert 2000 Vital Signs MonitorDXO · Traditional | Draeger Medical, Inc. | 07/28/1988SE |
| K874165 | Disposable Catheter Pressure TransducerDXO · Traditional | Deseret Medical, Inc. | 06/09/1988SE |
| K872291 | Escort Portable Patient MonitorDXO · Traditional | Medical Data Electronics | 09/25/1987SE |
| K863969 | Camino Compartmental Press Monitor CATH/110-4DDXO · Traditional | Camino Laboratories, Inc. | 05/27/1987SE |
| K864000 | FST Disposable Fiber Optic Transducer #0100-00DXO · Traditional | Fiberoptic Sensor Technlogies, Inc. | 01/16/1987SE |
| K860526 | Nova Balloon Thermodilution Pressure Trans CathDXO · Traditional | Nova Medical Specialties | 05/02/1986SE |
| K843969 | Model P23XL Physiological Pressure TransducerDXO · Traditional | Gould, Inc. | 01/23/1985SE |
| K842213 | VSM R1DXO · Traditional | Physio-Control Corp. | 10/26/1984SE |
| K842150 | Transducer-Monitor InterfacingDXO · Traditional | Millar Instruments, Inc. | 10/26/1984SE |
| K842005 | Model 110-5 & 140-8DXO · Traditional | Camino Laboratories, Inc. | 08/03/1984SE |
| K834040 | Minature Pressure TransducerDXO · Traditional | Carbomedics, Inc. | 02/10/1984SE |
| K832384 | BP Transducer Holders TH-2,3 & 4DXO · Traditional | American Bentley | 11/14/1983SE |
| K832604 | Physiological Pressure Measurement CathDXO · Traditional | Camino Laboratories, Inc. | 10/20/1983SE |
| K832579 | Physiological Press. Measurement CathDXO · Traditional | Camino Laboratories, Inc. | 10/20/1983SE |
| K830638 | Physiological Pressure Measurement SysDXO · Traditional | Camino Laboratories, Inc. | 04/18/1983SE |
| K801756 | Mmi/Gaeltec Catheter Tip TransducDXO · Traditional | Medical Measurements, Inc. | 08/20/1980SE |
| K792177 | Millar Mikro-Tip Catheter TransducerDXO · Traditional | Millar Instruments, Inc. | 11/15/1979SE |
| K790036 | Digital BPMDXO · Traditional | Narco Air-Shields | 03/02/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1966-2021 Class II | Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx Only, CE UDI:…There is a potential that the pressure tubing may detach from the blood sampling system | Edwards Lifesciences, LLC | 05/26/2021Terminated |
| Z-1965-2021 Class II | Edwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx Only, CE…There is a potential that the pressure tubing may detach from the blood sampling system | Edwards Lifesciences, LLC | 05/26/2021Terminated |
| Z-1964-2021 Class II | Edwards TruWave (30 cc)/VAMP Jr Kit, REF: VMP306PX, Pressure Monitoring Set, Rx Only…There is a potential that the pressure tubing may detach from the blood sampling system | Edwards Lifesciences, LLC | 05/26/2021Terminated |
| Z-1963-2021 Class II | Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use…There is a potential that the pressure tubing may detach from the blood sampling system | Edwards Lifesciences, LLC | 05/26/2021Terminated |
| Z-1962-2021 Class II | Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI:…There is a potential that the pressure tubing may detach from the blood sampling system | Edwards Lifesciences, LLC | 05/26/2021Terminated |
| Z-1961-2021 Class II | Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring…There is a potential that the pressure tubing may detach from the blood sampling system | Edwards Lifesciences, LLC | 05/26/2021Terminated |
| Z-1960-2021 Class II | Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXVJ0711, Pressure Monitoring…There is a potential that the pressure tubing may detach from the blood sampling system | Edwards Lifesciences, LLC | 05/26/2021Terminated |
| Z-1959-2021 Class II | Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Monitoring…There is a potential that the pressure tubing may detach from the blood sampling system | Edwards Lifesciences, LLC | 05/26/2021Terminated |
| Z-0446-2016 Class II | Intravascular (IV) Administration Sets, Model No. 54IV12, 54IV22, 54IV32, MK2450…Edward Lifesciences is recalling Intravascular (IV) Administration Sets due to the requirement of an… | Edwards Lifesciences, LLC | 11/13/2015Terminated |
| Z-2776-2015 Class II | Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile…Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. A restriction of… | Edward Lifesciences, Llc | 07/31/2015Terminated |