The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Vision Blood Cardioplegia System And Extracorporeal Heat Exchanger.
| Device ID | K020106 |
| 510k Number | K020106 |
| Device Name: | VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPOREAL HEAT EXCHANGER |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | GISH BIOMEDICAL, INC. 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 |
| Contact | James H Knauss |
| Correspondent | James H Knauss GISH BIOMEDICAL, INC. 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-11 |
| Decision Date | 2002-04-10 |
| Summary: | summary |