K992657 is an FDA 510(k) clearance for the IBC VRV, MODEL 1350. This device is classified as a Suction Control, Intracardiac, Cardiopulmonary Bypass (Class II - Special Controls, product code DWD).
Submitted by International Biophysics Corp. (Austin, US). The FDA issued a Cleared decision on February 18, 2000, 193 days after receiving the submission on August 9, 1999.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4430.
| 510(k) Number | K992657 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 1999 |
| Decision Date | February 18, 2000 |
| Days to Decision | 193 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DWD — Suction Control, Intracardiac, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4430 |