The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Robicsek Intracardiac Suction Wand.
| Device ID | K891906 |
| 510k Number | K891906 |
| Device Name: | ROBICSEK INTRACARDIAC SUCTION WAND |
| Classification | Sucker, Cardiotomy Return, Cardiopulmonary Bypass |
| Applicant | GISH BIOMEDICAL, INC. 2350 S. PULLMAN AVE. Santa Ana, CA 92705 |
| Contact | Lori Glastetter |
| Correspondent | Lori Glastetter GISH BIOMEDICAL, INC. 2350 S. PULLMAN AVE. Santa Ana, CA 92705 |
| Product Code | DTS |
| CFR Regulation Number | 870.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-27 |
| Decision Date | 1989-06-13 |