The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Vascuter External Reinforce Triaxial Prostheses.
| Device ID | K853101 |
| 510k Number | K853101 |
| Device Name: | VASCUTER EXTERNAL REINFORCE TRIAXIAL PROSTHESES |
| 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 | 1985-07-23 |
| Decision Date | 1986-02-24 |