The following data is part of a premarket notification filed by Bridgepoint Medical with the FDA for Mantaray Catheter.
| Device ID | K120129 |
| 510k Number | K120129 |
| Device Name: | MANTARAY CATHETER |
| Classification | Catheter, Percutaneous |
| 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 | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-17 |
| Decision Date | 2012-02-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821684073797 | K120129 | 000 |
| 00821684073780 | K120129 | 000 |