The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Flexible Intracardiac Suction Device.
| Device ID | K905008 |
| 510k Number | K905008 |
| Device Name: | FLEXIBLE INTRACARDIAC SUCTION DEVICE |
| Classification | Sucker, Cardiotomy Return, Cardiopulmonary Bypass |
| Applicant | GISH BIOMEDICAL, INC. 2350 S. PULLMAN AVE. Santa Ana, CA 92705 |
| Contact | Debi Kridner |
| Correspondent | Debi Kridner GISH BIOMEDICAL, INC. 2350 S. PULLMAN AVE. Santa Ana, CA 92705 |
| Product Code | DTS |
| CFR Regulation Number | 870.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-06 |
| Decision Date | 1991-01-23 |