The following data is part of a premarket notification filed by Bridgepoint Medical with the FDA for Stingray Orienting Balloon Catheter.
| Device ID | K101591 |
| 510k Number | K101591 |
| Device Name: | STINGRAY ORIENTING BALLOON CATHETER |
| Classification | Catheter, Percutaneous |
| 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 | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-07 |
| Decision Date | 2010-08-06 |
| Summary: | summary |