The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Duracath, Gish Model No. Dvac-xxxx.
| Device ID | K863792 |
| 510k Number | K863792 |
| Device Name: | DURACATH, GISH MODEL NO. DVAC-XXXX |
| Classification | Catheter, Conduction, Anesthetic |
| Applicant | GISH BIOMEDICAL, INC. 2350 S. PULLMAN AVE. Santa Ana, CA 92705 |
| Contact | Jeanne Pierson |
| Correspondent | Jeanne Pierson GISH BIOMEDICAL, INC. 2350 S. PULLMAN AVE. Santa Ana, CA 92705 |
| Product Code | BSO |
| CFR Regulation Number | 868.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-26 |
| Decision Date | 1986-12-05 |