The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Gish Cap Vrf45 Cardiotomy/venous Reservoir.
| Device ID | K964973 |
| 510k Number | K964973 |
| Device Name: | GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | GISH BIOMEDICAL, INC. 2681 KELVIN AVE. Irvine, CA 92614 -5821 |
| Contact | Jeff Dumontelle |
| Correspondent | Jeff Dumontelle GISH BIOMEDICAL, INC. 2681 KELVIN AVE. Irvine, CA 92614 -5821 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-12 |
| Decision Date | 1997-03-10 |
| Summary: | summary |