The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Single Pass Blood Cardioplegia Spbc System Components.
| Device ID | K944219 |
| 510k Number | K944219 |
| Device Name: | SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | GISH BIOMEDICAL, INC. 2681 KELVIN AVE. Irvine, CA 92614 -5821 |
| Contact | Debra J Kridner |
| Correspondent | Debra J Kridner GISH BIOMEDICAL, INC. 2681 KELVIN AVE. Irvine, CA 92614 -5821 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-29 |
| Decision Date | 1995-06-30 |