The following data is part of a premarket notification filed by Bridgepoint Medical with the FDA for Bigboss Catheters Mantatay Catheter Mantaray Guidewires.
| Device ID | K120533 |
| 510k Number | K120533 |
| Device Name: | BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES |
| Classification | Catheter For Crossing Total Occlusions |
| 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 | PDU |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-22 |
| Decision Date | 2012-05-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821684073841 | K120533 | 000 |
| 00821684052723 | K120533 | 000 |
| 00821684052730 | K120533 | 000 |
| 00821684052747 | K120533 | 000 |
| 00821684052754 | K120533 | 000 |
| 00821684052761 | K120533 | 000 |
| 00821684052778 | K120533 | 000 |
| 00821684073742 | K120533 | 000 |
| 00821684073759 | K120533 | 000 |
| 00821684073780 | K120533 | 000 |
| 00821684073797 | K120533 | 000 |
| 00821684073827 | K120533 | 000 |
| 00821684073834 | K120533 | 000 |
| 00821684052716 | K120533 | 000 |