The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Comet Pressure Guidewire.
| Device ID | K151610 |
| 510k Number | K151610 |
| Device Name: | Comet Pressure Guidewire |
| Classification | Transducer, Pressure, Catheter Tip |
| Applicant | BOSTON SCIENTIFIC CORPORATION 47215 LAKEVIEW BOULEVARD Fremont, CA 94538 |
| Contact | James Kleinedler |
| Correspondent | James Kleinedler BOSTON SCIENTIFIC CORPORATION 47215 LAKEVIEW BOULEVARD Fremont, CA 94538 |
| Product Code | DXO |
| CFR Regulation Number | 870.2870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-15 |
| Decision Date | 2015-10-06 |
| Summary: | summary |