The following data is part of a premarket notification filed by Cormatrix Cardiovascular, Inc. with the FDA for Cormatrix Tyke.
| Device ID | K152127 |
| 510k Number | K152127 |
| Device Name: | CorMatrix Tyke |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | CORMATRIX CARDIOVASCULAR, INC. 1100 OLD ELLIS ROAD Roswell, GA 30076 |
| Contact | Andrew M. Green |
| Correspondent | Andrew M. Green CORMATRIX CARDIOVASCULAR, INC. 1100 OLD ELLIS ROAD Roswell, GA 30076 |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-31 |
| Decision Date | 2016-02-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10859389005109 | K152127 | 000 |