The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Cathcap, Cat. No. Cc100 Series.
| Device ID | K911519 |
| 510k Number | K911519 |
| Device Name: | CATHCAP, CAT. NO. CC100 SERIES |
| Classification | Catheter, Percutaneous |
| Applicant | GISH BIOMEDICAL, INC. 2350 S. PULLMAN AVE. Santa Ana, CA 92705 |
| Contact | Debi Kridner |
| Correspondent | Debi Kridner 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 | 1991-04-04 |
| Decision Date | 1991-05-22 |