K151610 is an FDA 510(k) clearance for the Comet Pressure Guidewire. This device is classified as a Transducer, Pressure, Catheter Tip (Class II - Special Controls, product code DXO).
Submitted by Boston Scientific Corporation (Fremont, US). The FDA issued a Cleared decision on October 6, 2015, 113 days after receiving the submission on June 15, 2015.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2870.
| 510(k) Number | K151610 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 2015 |
| Decision Date | October 06, 2015 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXO — Transducer, Pressure, Catheter Tip |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2870 |