The following data is part of a premarket notification filed by Solinas Medical Inc with the FDA for Smi Cardiovascular Patch.
| Device ID | K122105 |
| 510k Number | K122105 |
| Device Name: | SMI CARDIOVASCULAR PATCH |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | SOLINAS MEDICAL INC 443 COSTA MESA TERRACE Sunny Vale, CA 94089 |
| Contact | James Hong |
| Correspondent | James Hong SOLINAS MEDICAL INC 443 COSTA MESA TERRACE Sunny Vale, CA 94089 |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-17 |
| Decision Date | 2012-12-07 |
| Summary: | summary |