The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Vascutek Vascular Prostheses, Extra Soft/low Woven.
| Device ID | K861808 |
| 510k Number | K861808 |
| Device Name: | VASCUTEK VASCULAR PROSTHESES, EXTRA SOFT/LOW WOVEN |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | COBE LABORATORIES, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Contact | Vera Buffaloe |
| Correspondent | Vera Buffaloe COBE LABORATORIES, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-09 |
| Decision Date | 1986-09-15 |