The following data is part of a premarket notification filed by Cormatrix Cardiovascular, Inc. with the FDA for Cormatrix Cor Patch (3 Cm X 5 Cm)(single Pack), Cormatrix Cor Patch (4 Cm X 7 Cm)(single Pack), Cormatrix Cor Patch (7 Cm X 10 Cm)(single Pack).
| Device ID | K181038 |
| 510k Number | K181038 |
| Device Name: | CorMatrix Cor Patch (3 Cm X 5 Cm)(single Pack), CorMatrix Cor Patch (4 Cm X 7 Cm)(single Pack), CorMatrix Cor Patch (7 Cm X 10 Cm)(single Pack) |
| Classification | Intracardiac Patch Or Pledget, Biologically Derived |
| Applicant | CorMatrix Cardiovascular, Inc. 1100 Old Ellis Rd. Roswell, GA 30076 |
| Contact | Wendy Perreault |
| Correspondent | Wendy Perreault New South Regulatory, LLC 223 Coventry Road Decatur, GA 30030 |
| Product Code | PSQ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-19 |
| Decision Date | 2018-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850003965017 | K181038 | 000 |
| 00850003965000 | K181038 | 000 |