The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Antegrade/retrograde Cardioplegia Valve Systems.
| Device ID | K922840 |
| 510k Number | K922840 |
| Device Name: | ANTEGRADE/RETROGRADE CARDIOPLEGIA VALVE SYSTEMS |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | GISH BIOMEDICAL, INC. 2350 S. PULLMAN AVE. Santa Ana, CA 92705 |
| Contact | Brian Strauss |
| Correspondent | Brian Strauss GISH BIOMEDICAL, INC. 2350 S. PULLMAN AVE. Santa Ana, CA 92705 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-12 |
| Decision Date | 1993-05-17 |