The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Cobe Catheter W/guidewire Assembly Kit.
| Device ID | K853100 |
| 510k Number | K853100 |
| Device Name: | COBE CATHETER W/GUIDEWIRE ASSEMBLY KIT |
| Classification | Introducer, Catheter |
| 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 | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-23 |
| Decision Date | 1985-09-25 |