The following data is part of a premarket notification filed by Cook Biotech, Inc. with the FDA for Surgisis Peripheral Vascular Patch.
| Device ID | K001785 |
| 510k Number | K001785 |
| Device Name: | SURGISIS PERIPHERAL VASCULAR PATCH |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | COOK BIOTECH, INC. 3055 KENT AVE. West Lafayette, IN 47906 -1076 |
| Contact | Neal E Fearnot |
| Correspondent | Neal E Fearnot COOK BIOTECH, INC. 3055 KENT AVE. West Lafayette, IN 47906 -1076 |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-13 |
| Decision Date | 2000-12-27 |