The following data is part of a premarket notification filed by Mast Biosurgery Usa Inc. with the FDA for Cardio-wrap.
| Device ID | K090637 |
| 510k Number | K090637 |
| Device Name: | CARDIO-WRAP |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | MAST BIOSURGERY USA INC. 6749 TOP GUN ST., SUITE C San Diego, CA 92121 |
| Contact | Kenneth K Kleinhenz |
| Correspondent | Kenneth K Kleinhenz MAST BIOSURGERY USA INC. 6749 TOP GUN ST., SUITE C San Diego, CA 92121 |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-10 |
| Decision Date | 2010-01-07 |
| Summary: | summary |