The following data is part of a premarket notification filed by Bridgepoint Medical with the FDA for Mantaray Guidewires.
| Device ID | K121745 |
| 510k Number | K121745 |
| Device Name: | MANTARAY GUIDEWIRES |
| Classification | Wire, Guide, Catheter |
| Applicant | BRIDGEPOINT MEDICAL 13355 10TH AVE N, SUITE #110 Plymouth, MN 55441 |
| Contact | Jill Munsinger |
| Correspondent | Jill Munsinger BRIDGEPOINT MEDICAL 13355 10TH AVE N, SUITE #110 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 | 2012-06-14 |
| Decision Date | 2012-07-13 |
| Summary: | summary |