Comet Pressure Guidewire
FDA 510(k) clearance K151610 · decided 2015-10-06
Clearance details
- K-number
- K151610
- Device name
- Comet Pressure Guidewire
- Applicant
- Boston Scientific Corporation
- Decision
- Substantially Equivalent
- Date received
- 2015-06-15
- Decision date
- 2015-10-06
- Days to decision
- 113 days
- Clearance type
- Traditional
- Product code
- DXO
- Device class
- 2
- Regulation number
- 870.2870
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Fremont, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Boston Scientific Corporation
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OptoMonitor 3 (K251367) | Opsens, Inc. | 2026-01-16 |
| OptoMonitor 3 (K241418) | Opsens, Inc. | 2025-02-12 |
| ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ (K233904) | Acist Medical Systems, Inc. | 2024-07-17 |
| TruWave Disposable Pressure Transducer (K222216) | Edwards Lifesciences, LLC | 2022-12-22 |
| OptoMonitor 3 (K202943) | Opsens, Inc. | 2020-11-24 |
| OptoMonitor 3 (K193620) | Opsens, Inc. | 2020-06-18 |
| Comet II Pressure Guidewire (K193279) | Boston Scientific Corporation | 2019-12-23 |
| OptoMonitor (K192340) | Opsens, Inc. | 2019-12-12 |
| Zurich Pressure Guidewire System Model 100 (K190852) | Zurich Medical, Inc. | 2019-08-14 |
| TruWave Disposable Pressure Transducer (K183413) | Edwards Lifeciences, LLC | 2019-05-01 |
| PressureWire X (K180558) | St. Jude Medical (Now Part of Abbott Medical) | 2018-03-28 |
| TruWave Disposable Pressure Transducer (K171996) | Edwards Lifesciences, LLC | 2017-10-23 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Axonics Sacral Neuromodulation System (P190006/S101) | Boston Scientific Corporation | 2025-12-19 |
| Axonics Sacral Neuromodulation System (P180046/S101) | Boston Scientific Corporation | 2025-12-19 |
| SYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S110) | Boston Scientific Corporation | 2025-10-29 |
| Innova Vascular Self-Expanding Stent System (P140028/S084) | Boston Scientific Corporation | 2025-10-24 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S039) | Boston Scientific Corporation | 2025-10-24 |
| AGENT Paclitaxel-Coated Balloon Catheter (P230035/S007) | Boston Scientific Corporation | 2025-10-24 |
| ENROUTE® Transcarotid Stent System (P140026/S032) | Boston Scientific Corporation | 2025-10-23 |
| A209 SICD Gen 2,A219 SICD MRI (P110042/S206) | Boston Scientific Corporation | 2025-10-22 |