Product code DXO
- Device name
- Transducer, Pressure, Catheter Tip
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.2870
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251367 | OptoMonitor 3 | Opsens, Inc. | 2026-01-16 |
| K241418 | OptoMonitor 3 | Opsens, Inc. | 2025-02-12 |
| K233904 | ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ | Acist Medical Systems, Inc. | 2024-07-17 |
| K222216 | TruWave Disposable Pressure Transducer | Edwards Lifesciences, LLC | 2022-12-22 |
| K202943 | OptoMonitor 3 | Opsens, Inc. | 2020-11-24 |
| K193620 | OptoMonitor 3 | Opsens, Inc. | 2020-06-18 |
| K193279 | Comet II Pressure Guidewire | Boston Scientific Corporation | 2019-12-23 |
| K192340 | OptoMonitor | Opsens, Inc. | 2019-12-12 |
| K190852 | Zurich Pressure Guidewire System Model 100 | Zurich Medical, Inc. | 2019-08-14 |
| K183413 | TruWave Disposable Pressure Transducer | Edwards Lifeciences, LLC | 2019-05-01 |
| K180558 | PressureWire X | St. Jude Medical (Now Part of Abbott Medical) | 2018-03-28 |
| K171996 | TruWave Disposable Pressure Transducer | Edwards Lifesciences, LLC | 2017-10-23 |
| K163376 | Mikro-Cath Pressure Catheter | Millar, Inc. | 2017-03-10 |
| K161263 | OptoMonitor II | Opsens, Inc. | 2016-09-13 |
| K161171 | PressureWire X Guidewire | St. Jude Medical, Inc. | 2016-08-15 |
| K151610 | Comet Pressure Guidewire | Boston Scientific Corporation | 2015-10-06 |
| K142749 | TruWave Disposable Pressure Transducer | Edwards Lifesciences, LLC | 2015-01-18 |
| K140466 | PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGILE TIP 300 | St. Jude Medical Systems AB | 2014-11-13 |
| K141495 | TRUWAVE DISPOSABLE PRESSURE TRANSDUCER | Edwards Lifesciences, LLC | 2014-09-03 |
| K132474 | CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER | Acist Medical Systems | 2014-01-30 |
| K131452 | PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300 | St. Jude Medical Systems AB | 2013-09-05 |
| K113584 | PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER | St Jude Medical | 2012-03-02 |
| K112323 | CARDIA-CATH | Millar Instruments, Inc. | 2011-10-18 |
| K093111 | MIKRO-CATH, MODEL 825-0101 | Millar Instruments, Inc. | 2010-01-05 |
| K080813 | PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER | Radi Medical Systems AB | 2008-07-01 |
| K070487 | SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX | Volcano Corporation | 2007-03-16 |
| K062769 | PRESSUREWIRE CERTUS, MODELS 12006 AND 12306 | Radi Medical Systems AB | 2006-12-04 |
| K053016 | WIRELESS PHYSIOLOGIC MONITORING SYSTEM | Edwards Lifesciences, LLC | 2005-12-30 |
| K031662 | PRESSURE WIRE SENSOR, MODELS 12004/12304 | Radi Medical Systems AB | 2003-06-06 |
| K022187 | PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304 | Radi Medical Systems AB | 2002-09-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10888277804128 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2023-07-29 |
| 10888277655379 | Medline | MEDLINE INDUSTRIES, INC. | 2020-12-25 |
| 00690103199406 | TRUWAVE, VAMP JR. | Edwards Lifesciences LLC | 2020-08-26 |
| 00690103197129 | TRUWAVE, VAMP PLUS | Edwards Lifesciences LLC | 2020-04-24 |
| 00690103197136 | TRUWAVE/VAMP | Edwards Lifesciences LLC | 2020-04-23 |
| 00690103197693 | TRUWAVE/ VAMP PLUS | Edwards Lifesciences LLC | 2019-07-03 |
| 00690103197686 | TRUWAVE(3 CC)/ VAMP PLUS 86 IN (218 CM) | Edwards Lifesciences LLC | 2019-05-30 |
| 00690103200003 | TruWave, VAMP Plus | Edwards Lifesciences LLC | 2019-05-30 |
| 00690103200324 | Combo Kit | Edwards Lifesciences LLC | 2019-04-17 |
| 00690103200287 | TruWave, VAMP Jr. | Edwards Lifesciences LLC | 2019-04-17 |
| 00690103200300 | Combo Kit | Edwards Lifesciences LLC | 2019-04-17 |
| 00690103200317 | Combo Kit | Edwards Lifesciences LLC | 2019-04-17 |
| 10884450410926 | Merit Medical® | ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. | 2019-03-08 |
| 10884450323189 | P23XL™ | ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. | 2018-11-27 |
| 00690103149678 | TRUWAVE | Edwards Lifesciences LLC | 2018-08-14 |
| 00690103148329 | TRUWAVE | Edwards Lifesciences LLC | 2018-08-07 |
| 00690103011548 | TruWave | Edwards Lifesciences LLC | 2018-07-23 |
| 10841716101240 | ACIST Navvus® Catheter | ACIST MEDICAL SYSTEMS, INC. | 2017-08-15 |
| 20884389102517 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10884389106136 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196172405 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 08714729904397 | Comet | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729904403 | Comet | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729875758 | Comet | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 10841716100007 | ACIST Navvus® Catheter | ACIST MEDICAL SYSTEMS, INC. | 2016-09-09 |
| 00690103161830 | TRUWAVE, VAMP | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103160468 | TRUWAVE, VAMP PLUS | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103016802 | TRUWAVE, VAMP | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103016765 | TRUWAVE, VAMP | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103011494 | TRUWAVE, VAMP | Edwards Lifesciences LLC | 2016-09-03 |