The following data is part of a premarket notification filed by Cryolife, Inc. with the FDA for Cryopatch Sg Pulmonary Human Cardiac Patch.
| Device ID | K101866 |
| 510k Number | K101866 |
| Device Name: | CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | CRYOLIFE, INC. 1655 ROBERTS BLVD., N.W. Kennesaw, GA 30144 |
| Contact | John D Ferros |
| Correspondent | John D Ferros CRYOLIFE, INC. 1655 ROBERTS BLVD., N.W. Kennesaw, GA 30144 |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-02 |
| Decision Date | 2010-07-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00877234000485 | K101866 | 000 |
| 00877234000478 | K101866 | 000 |
| 00877234000461 | K101866 | 000 |