The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Cardioplegia System Ccs-xxx Series.
| Device ID | K833662 |
| 510k Number | K833662 |
| Device Name: | CARDIOPLEGIA SYSTEM CCS-XXX SERIES |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | GISH BIOMEDICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-18 |
| Decision Date | 1983-12-29 |