The following data is part of a premarket notification filed by Bridger Biomed, Inc. with the FDA for Fluoro-tex Cardiovascular Patch.
| Device ID | K994032 |
| 510k Number | K994032 |
| Device Name: | FLUORO-TEX CARDIOVASCULAR PATCH |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | BRIDGER BIOMED, INC. 2430 NORTH 7TH AVE., SUITE 4 Bozeman, MT 59715 |
| Contact | Bruce G Ruefer |
| Correspondent | Bruce G Ruefer BRIDGER BIOMED, INC. 2430 NORTH 7TH AVE., SUITE 4 Bozeman, MT 59715 |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-26 |
| Decision Date | 2000-07-07 |
| Summary: | summary |