The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Hurwitz Dialysis Catheter.
| Device ID | K860094 |
| 510k Number | K860094 |
| Device Name: | HURWITZ DIALYSIS CATHETER |
| Classification | Catheter, Subclavian |
| 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 | LFJ |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-10 |
| Decision Date | 1986-04-07 |