The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Hand-held Intracardiac Suckers W/ergonomic Handles.
| Device ID | K900339 |
| 510k Number | K900339 |
| Device Name: | HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES |
| Classification | Sucker, Cardiotomy Return, Cardiopulmonary Bypass |
| Applicant | SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Contact | Abati, Ph.d |
| Correspondent | Abati, Ph.d SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Product Code | DTS |
| CFR Regulation Number | 870.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-23 |
| Decision Date | 1990-03-28 |