The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Cardiotomy/autotransfusion/pleural Drainage Venous.
| Device ID | K890504 |
| 510k Number | K890504 |
| Device Name: | CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS |
| Classification | Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass |
| Applicant | GISH BIOMEDICAL, INC. 2350 S. PULLMAN AVE. Santa Ana, CA 92705 |
| Contact | Lori Glastetter |
| Correspondent | Lori Glastetter GISH BIOMEDICAL, INC. 2350 S. PULLMAN AVE. Santa Ana, CA 92705 |
| Product Code | JOD |
| CFR Regulation Number | 870.4270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-01 |
| Decision Date | 1989-03-10 |