The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Comet Ii Pressure Guidewire.
| Device ID | K193279 |
| 510k Number | K193279 |
| Device Name: | Comet II Pressure Guidewire |
| Classification | Transducer, Pressure, Catheter Tip |
| Applicant | Boston Scientific Corporation Three Scimed Place Maple Grove, MN 55311 -1566 |
| Contact | Kimberly Berg |
| Correspondent | Kimberly Berg Boston Scientific Corporation Three Scimed Place Maple Grove, MN 55311 -1566 |
| Product Code | DXO |
| CFR Regulation Number | 870.2870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-27 |
| Decision Date | 2019-12-23 |
| Summary: | summary |