The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Gish Vision Blood Cardioplegia With Ha Coating.
| Device ID | K081838 |
| 510k Number | K081838 |
| Device Name: | GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | GISH BIOMEDICAL, INC. 22942 ARROYO VISTA Rancho Santa Margarita, CA 92688 |
| Contact | Martin Sellers |
| Correspondent | Martin Sellers GISH BIOMEDICAL, INC. 22942 ARROYO VISTA Rancho Santa Margarita, CA 92688 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-30 |
| Decision Date | 2009-01-26 |
| Summary: | summary |