The following data is part of a premarket notification filed by Bridgepoint Medical with the FDA for Stingray Guidewire, Stiff, Models M-3003, M-3004, M-3011, M-3012.
| Device ID | K083727 |
| 510k Number | K083727 |
| Device Name: | STINGRAY GUIDEWIRE, STIFF, MODELS M-3003, M-3004, M-3011, M-3012 |
| Classification | Wire, Guide, Catheter |
| Applicant | BRIDGEPOINT MEDICAL 2800 CAMPUS DRIVE #50 Plymouth, MN 55441 |
| Contact | Jill Munsinger |
| Correspondent | Jill Munsinger BRIDGEPOINT MEDICAL 2800 CAMPUS DRIVE #50 Plymouth, MN 55441 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-15 |
| Decision Date | 2009-02-20 |
| Summary: | summary |