The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Subclavian, Gish Model No. Svac-xxxx.
| Device ID | K863791 |
| 510k Number | K863791 |
| Device Name: | SUBCLAVIAN, GISH MODEL NO. SVAC-XXXX |
| Classification | Catheter, Percutaneous |
| 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 | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-26 |
| Decision Date | 1987-06-25 |