K963756 is an FDA 510(k) clearance for the IBC CARDIAC SUCTION WARD. This device is classified as a Sucker, Cardiotomy Return, Cardiopulmonary Bypass (Class II - Special Controls, product code DTS).
Submitted by International Biophysics Corp. (Austin, US). The FDA issued a Cleared decision on November 14, 1997, 423 days after receiving the submission on September 17, 1996.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4420.
| 510(k) Number | K963756 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 17, 1996 |
| Decision Date | November 14, 1997 |
| Days to Decision | 423 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTS — Sucker, Cardiotomy Return, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4420 |