FDA Product Code
FDA Product Code DXO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2870
510(k) Clearances — 64 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251367 | OptoMonitor 3 | Opsens, Inc. | 2026-01-16 | Traditional | PDF ↗ |
| K241418 | OptoMonitor 3 | Opsens, Inc. | 2025-02-12 | Traditional | PDF ↗ |
| K233904 | ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ | Acist Medical Systems, Inc. | 2024-07-17 | Traditional | PDF ↗ |
| K222216 | TruWave Disposable Pressure Transducer | Edwards Lifesciences, LLC | 2022-12-22 | Traditional | PDF ↗ |
| K202943 | OptoMonitor 3 | Opsens, Inc. | 2020-11-24 | Traditional | PDF ↗ |
| K193620 | OptoMonitor 3 | Opsens, Inc. | 2020-06-18 | Traditional | PDF ↗ |
| K193279 | Comet II Pressure Guidewire | Boston Scientific Corporation | 2019-12-23 | Special | PDF ↗ |
| K192340 | OptoMonitor | Opsens, Inc. | 2019-12-12 | Traditional | PDF ↗ |
| K190852 | Zurich Pressure Guidewire System Model 100 | Zurich Medical, Inc. | 2019-08-14 | Traditional | PDF ↗ |
| K183413 | TruWave Disposable Pressure Transducer | Edwards Lifeciences, LLC | 2019-05-01 | Traditional | PDF ↗ |
| K180558 | PressureWire X | St. Jude Medical (Now Part of Abbott Medical) | 2018-03-28 | Special | PDF ↗ |
| K171996 | TruWave Disposable Pressure Transducer | Edwards Lifesciences, LLC | 2017-10-23 | Traditional | PDF ↗ |
| K163376 | Mikro-Cath Pressure Catheter | Millar, Inc. | 2017-03-10 | Traditional | PDF ↗ |
| K161263 | OptoMonitor II | Opsens, Inc. | 2016-09-13 | Traditional | PDF ↗ |
| K161171 | PressureWire X Guidewire | St. Jude Medical, Inc. | 2016-08-15 | Traditional | PDF ↗ |
| K151610 | Comet Pressure Guidewire | Boston Scientific Corporation | 2015-10-06 | Traditional | PDF ↗ |
| K142749 | TruWave Disposable Pressure Transducer | Edwards Lifesciences, LLC | 2015-01-18 | Traditional | PDF ↗ |
| K140466 | PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGILE TIP 300 | St. Jude Medical Systems AB | 2014-11-13 | Traditional | PDF ↗ |
| K141495 | TRUWAVE DISPOSABLE PRESSURE TRANSDUCER | Edwards Lifesciences, LLC | 2014-09-03 | Traditional | PDF ↗ |
| K132474 | CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER | Acist Medical Systems | 2014-01-30 | Traditional | PDF ↗ |
| K131452 | PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300 | St. Jude Medical Systems AB | 2013-09-05 | Traditional | PDF ↗ |
| K113584 | PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER | St Jude Medical | 2012-03-02 | Traditional | PDF ↗ |
| K112323 | CARDIA-CATH | Millar Instruments, Inc. | 2011-10-18 | Special | PDF ↗ |
| K093111 | MIKRO-CATH, MODEL 825-0101 | Millar Instruments, Inc. | 2010-01-05 | Abbreviated | PDF ↗ |
| K080813 | PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER | Radi Medical Systems AB | 2008-07-01 | Traditional | PDF ↗ |
| K070487 | SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX | Volcano Corporation | 2007-03-16 | Special | PDF ↗ |
| K062769 | PRESSUREWIRE CERTUS, MODELS 12006 AND 12306 | Radi Medical Systems AB | 2006-12-04 | Special | PDF ↗ |
| K053016 | WIRELESS PHYSIOLOGIC MONITORING SYSTEM | Edwards Lifesciences, LLC | 2005-12-30 | Traditional | PDF ↗ |
| K031662 | PRESSURE WIRE SENSOR, MODELS 12004/12304 | Radi Medical Systems AB | 2003-06-06 | Special | PDF ↗ |
| K022187 | PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304 | Radi Medical Systems AB | 2002-09-24 | Traditional | PDF ↗ |
| K935166 | FLOW DIRECTED MIKRO-TIP PRESSURE TRANSDUCER | Millar Instruments, Inc. | 1994-08-05 | Traditional | PDF ↗ |
| K941283 | INNERSENSE DISPOSABLE MICROTRANSDUCER | Becton Dickinson Vascular Access, Inc. | 1994-04-19 | Traditional | PDF ↗ |
| K925638 | PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600 | Baxter Healthcare Corp | 1993-10-18 | Traditional | PDF ↗ |
| K924737 | INNERSENSE(TM) DISPOSABLE MICROTRANSDUCER | Becton Dickinson Vascular Access, Inc. | 1993-08-23 | Traditional | PDF ↗ |
| K920580 | TRANSDUCER, PRESSURE, CATHETER TIP | Medamicus, Inc. | 1993-01-07 | Traditional | PDF ↗ |
| K913042 | MODIFICATIONS TO SERIES OF CARDIAC CATHETERS | Sentron, Inc. | 1992-10-21 | Traditional | PDF ↗ |
| K915775 | MILLAR NONMAGNECTIC MIKRO-TIP CATHETER PRESS. TRAN | Millar Instruments, Inc. | 1992-04-20 | Traditional | PDF ↗ |
| K910429 | SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER | Baxter Healthcare Corp | 1991-07-11 | Traditional | PDF ↗ |
| K895721 | MILLAR MIKRO-TIP PULSE TRANSDUCER | Millar Instruments, Inc. | 1989-12-07 | Traditional | PDF ↗ |
| K894033 | DISPOSABLE CATHETER PRESSURE TRANSDUCER | Deseret Medical, Inc. | 1989-10-17 | Traditional | PDF ↗ |
| K894747 | PRECEPT-GT(TM) MICROSENSOR PRESSURE MONITOR CATH. | Endosonics Corp. | 1989-10-12 | Traditional | PDF ↗ |
| K894286 | PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER | Ppg Industries, Inc. | 1989-10-12 | Traditional | PDF ↗ |
| K890492 | PRECEPT-PT(TM) MICROSENSOR PRESSURE MONITOR CATH. | Endosonics Corp. | 1989-03-02 | Traditional | PDF ↗ |
| K883202 | ULTRASONIC IMAGING CATHETER | Boston Scientific Corp | 1988-11-23 | Traditional | PDF ↗ |
| K883436 | PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER | Ppg Industries, Inc. | 1988-10-17 | Traditional | PDF ↗ |
| K880830 | SENTORR ARTERIAL PRESSURE SENSOR | Ohmeda Medical | 1988-08-12 | Traditional | PDF ↗ |
| K882031 | VITALERT 2000 VITAL SIGNS MONITOR | Draeger Medical, Inc. | 1988-07-28 | Traditional | PDF ↗ |
| K874165 | DISPOSABLE CATHETER PRESSURE TRANSDUCER | Deseret Medical, Inc. | 1988-06-09 | Traditional | PDF ↗ |
| K872291 | ESCORT PORTABLE PATIENT MONITOR | Medical Data Electronics | 1987-09-25 | Traditional | PDF ↗ |
| K863969 | CAMINO COMPARTMENTAL PRESS MONITOR CATH/110-4D | Camino Laboratories, Inc. | 1987-05-27 | Traditional | PDF ↗ |
| K864000 | FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00 | Fiberoptic Sensor Technlogies, Inc. | 1987-01-16 | Traditional | PDF ↗ |
| K860526 | NOVA BALLOON THERMODILUTION PRESSURE TRANS CATH | Nova Medical Specialties | 1986-05-02 | Traditional | PDF ↗ |
| K843969 | MODEL P23XL PHYSIOLOGICAL PRESSURE TRANSDUCER | Gould, Inc. | 1985-01-23 | Traditional | PDF ↗ |
| K842150 | TRANSDUCER-MONITOR INTERFACING | Millar Instruments, Inc. | 1984-10-26 | Traditional | PDF ↗ |
| K842213 | VSM R1 | Physio-Control Corp. | 1984-10-26 | Traditional | PDF ↗ |
| K842005 | MODEL 110-5 & 140-8 | Camino Laboratories, Inc. | 1984-08-03 | Traditional | PDF ↗ |
| K834040 | MINATURE PRESSURE TRANSDUCER | Carbomedics, Inc. | 1984-02-10 | Traditional | PDF ↗ |
| K832384 | BP TRANSDUCER HOLDERS TH-2,3 & 4 | American Bentley | 1983-11-14 | Traditional | PDF ↗ |
| K832604 | PHYSIOLOGICAL PRESSURE MEASUREMENT CATH | Camino Laboratories, Inc. | 1983-10-20 | Traditional | PDF ↗ |
| K832579 | PHYSIOLOGICAL PRESS. MEASUREMENT CATH | Camino Laboratories, Inc. | 1983-10-20 | Traditional | PDF ↗ |
| K830638 | PHYSIOLOGICAL PRESSURE MEASUREMENT SYS | Camino Laboratories, Inc. | 1983-04-18 | Traditional | PDF ↗ |
| K801756 | MMI/GAELTEC CATHETER TIP TRANSDUC | Medical Measurements, Inc. | 1980-08-20 | Traditional | PDF ↗ |
| K792177 | MILLAR MIKRO-TIP CATHETER TRANSDUCER | Millar Instruments, Inc. | 1979-11-15 | Traditional | PDF ↗ |
| K790036 | DIGITAL BPM | Narco Air-Shields | 1979-03-02 | Traditional | PDF ↗ |
Product code DXO · Class II · Cardiovascular. Data: openFDA.