The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Heparinized Arterial Screen Blood Filter.
| Device ID | K900758 |
| 510k Number | K900758 |
| Device Name: | HEPARINIZED ARTERIAL SCREEN BLOOD FILTER |
| Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Applicant | COBE LABORATORIES, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Contact | Mary L Armstrong |
| Correspondent | Mary L Armstrong COBE LABORATORIES, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Product Code | DTM |
| CFR Regulation Number | 870.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-16 |
| Decision Date | 1990-05-17 |