The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Premipatch Ptfe Pledget.
| Device ID | K151865 |
| 510k Number | K151865 |
| Device Name: | PremiPatch PTFE Pledget |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | AESCULAP, INC. 3773 CORPORATE PARKWAY Center Valley, PA 18034 |
| Contact | Kathy A. Racosky |
| Correspondent | Kathy A. Racosky AESCULAP, INC. 3773 CORPORATE PARKWAY Center Valley, PA 18034 |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-08 |
| Decision Date | 2015-10-27 |
| Summary: | summary |