K900339 is an FDA 510(k) clearance for the HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES. This device is classified as a Sucker, Cardiotomy Return, Cardiopulmonary Bypass (Class II - Special Controls, product code DTS).
Submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on March 28, 1990, 64 days after receiving the submission on January 23, 1990.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4420.
| 510(k) Number | K900339 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 1990 |
| Decision Date | March 28, 1990 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DTS — Sucker, Cardiotomy Return, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4420 |