The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Vision Hollow Fiber Oxygenator With Guardian Coating.
| Device ID | K023381 |
| 510k Number | K023381 |
| Device Name: | VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | GISH BIOMEDICAL, INC. 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 |
| Contact | J. Harvey Knauss |
| Correspondent | J. Harvey Knauss GISH BIOMEDICAL, INC. 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-08 |
| Decision Date | 2003-03-31 |
| Summary: | summary |