The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Atr-2900df (with Depth Filter)/cap-35df (with Depth Filter).
| Device ID | K936286 |
| 510k Number | K936286 |
| Device Name: | ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER) |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | GISH BIOMEDICAL, INC. 2681 KELVIN AVE. Irvine, CA 92614 -5821 |
| Contact | Debra J Kridner |
| Correspondent | Debra J Kridner GISH BIOMEDICAL, INC. 2681 KELVIN AVE. Irvine, CA 92614 -5821 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-30 |
| Decision Date | 1994-02-14 |