The following data is part of a premarket notification filed by Bridgepoint Medical with the FDA for Mantaray Guidewire Model M-6000, M-6001, M-6002, M-6003.
| Device ID | K111488 |
| 510k Number | K111488 |
| Device Name: | MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003 |
| Classification | Wire, Guide, Catheter |
| Applicant | BRIDGEPOINT MEDICAL 2800 CAMPUS DR STE 50 Plymouth, MN 55441 |
| Contact | Jill Munsinger |
| Correspondent | Jill Munsinger BRIDGEPOINT MEDICAL 2800 CAMPUS DR STE 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 | 2011-05-31 |
| Decision Date | 2011-06-30 |