The following data is part of a premarket notification filed by Cormatrix Cardiovascular, Inc. with the FDA for Patch, Pledget And Intracardiac.
| Device ID | K111187 |
| 510k Number | K111187 |
| Device Name: | PATCH, PLEDGET AND INTRACARDIAC |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | CORMATRIX CARDIOVASCULAR, INC. 155 MOFFETT PARK DRIVE SUITE 210 Sunnyvale, CA 94089 |
| Contact | Kit Cariquitan |
| Correspondent | Kit Cariquitan CORMATRIX CARDIOVASCULAR, INC. 155 MOFFETT PARK DRIVE SUITE 210 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 | 2011-04-27 |
| Decision Date | 2011-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10859389005093 | K111187 | 000 |
| 10859389005086 | K111187 | 000 |