The following data is part of a premarket notification filed by Solimas Medical, Inc. with the FDA for Smi Cardiovascular Pach.
| Device ID | K112683 |
| 510k Number | K112683 |
| Device Name: | SMI CARDIOVASCULAR PACH |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | SOLIMAS MEDICAL, INC. 443 COSTA MESA TERRACE Sunnyvale, CA 94089 |
| Contact | Micheal Kolbe |
| Correspondent | Micheal Kolbe SOLIMAS MEDICAL, INC. 443 COSTA MESA TERRACE Sunnyvale, CA 94089 |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-15 |
| Decision Date | 2011-12-14 |
| Summary: | summary |