The following data is part of a premarket notification filed by Bridgepoint Medical with the FDA for Bridgepoint Medical Entera Percutaneous Coronary And Peripheral Guidewire, Model M-3001.
| Device ID | K081187 |
| 510k Number | K081187 |
| Device Name: | BRIDGEPOINT MEDICAL ENTERA PERCUTANEOUS CORONARY AND PERIPHERAL GUIDEWIRE, MODEL M-3001 |
| Classification | Wire, Guide, Catheter |
| 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 | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-28 |
| Decision Date | 2008-10-08 |
| Summary: | summary |