The following data is part of a premarket notification filed by Cryolife, Inc. with the FDA for Cryopatch Sg Pulmonary Hemi-artery; Trunk; Branch.
| Device ID | K091626 |
| 510k Number | K091626 |
| Device Name: | CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | CRYOLIFE, INC. 1655 ROBERTS BLVD., N.W. Kennesaw, GA 30144 |
| Contact | John Ferros |
| Correspondent | John Ferros CRYOLIFE, INC. 1655 ROBERTS BLVD., N.W. Kennesaw, GA 30144 |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-03 |
| Decision Date | 2009-08-07 |
| Summary: | summary |