The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Swank Cardiotomy Suction Line Blood Filter Ca100.
| Device ID | K855067 |
| 510k Number | K855067 |
| Device Name: | SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100 |
| Classification | Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass |
| 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 | JOD |
| CFR Regulation Number | 870.4270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-18 |
| Decision Date | 1986-02-26 |