The following data is part of a premarket notification filed by Bridgepoint Medical with the FDA for Bridgepoint Medical Crossboss Percutaneous Coronary Catheter.
| Device ID | K081130 |
| 510k Number | K081130 |
| Device Name: | BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | BRIDGEPOINT MEDICAL 8 SNOWBERRY COURT Orinda, CA 94563 |
| Contact | Michael A Daniel |
| Correspondent | Michael A Daniel BRIDGEPOINT MEDICAL 8 SNOWBERRY COURT Orinda, CA 94563 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-21 |
| Decision Date | 2009-05-14 |
| Summary: | summary |