K920936 is an FDA 510(k) clearance for the RMI EXTERNAL CORONARY ARTERY OCCLUDER. This device is classified as a Clamp, Vascular (Class II - Special Controls, product code DXC).
Submitted by Research Medical, Inc. (Midvale, US). The FDA issued a Cleared decision on December 18, 1992, 294 days after receiving the submission on February 28, 1992.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4450.
| 510(k) Number | K920936 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 1992 |
| Decision Date | December 18, 1992 |
| Days to Decision | 294 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DXC — Clamp, Vascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4450 |