The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Gish Arterial Filter.
| Device ID | K914791 |
| 510k Number | K914791 |
| Device Name: | GISH ARTERIAL FILTER |
| Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Applicant | GISH BIOMEDICAL, INC. 2350 S. PULLMAN AVE. Santa Ana, CA 92705 |
| Contact | Debra J Kridner |
| Correspondent | Debra J Kridner GISH BIOMEDICAL, INC. 2350 S. PULLMAN AVE. Santa Ana, CA 92705 |
| Product Code | DTM |
| CFR Regulation Number | 870.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-23 |
| Decision Date | 1993-04-06 |