K892377 is an FDA 510(k) clearance for the RMI AORTIC ROOT/CORONARY SINUS MONIT./INFUSION SET. This device is classified as a Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (Class II - Special Controls, product code DTL).
Submitted by Research Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on December 7, 1989, 245 days after receiving the submission on April 6, 1989.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4290.
| 510(k) Number | K892377 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 1989 |
| Decision Date | December 07, 1989 |
| Days to Decision | 245 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DTL — Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4290 |