The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Extracorporeal Heat Exchanger He Series.
| Device ID | K896020 |
| 510k Number | K896020 |
| Device Name: | EXTRACORPOREAL HEAT EXCHANGER HE SERIES |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | GISH BIOMEDICAL, INC. 2350 S. PULLMAN AVE. Santa Ana, CA 92705 |
| Contact | Mary Dearmond |
| Correspondent | Mary Dearmond GISH BIOMEDICAL, INC. 2350 S. PULLMAN AVE. Santa Ana, CA 92705 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-16 |
| Decision Date | 1990-05-17 |