K910221 is an FDA 510(k) clearance for the RMI VASCULAR TOURNIQUET KIT. This device is classified as a Clamp, Vascular (Class II - Special Controls, product code DXC).
Submitted by Research Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on May 16, 1991, 119 days after receiving the submission on January 17, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4450.
| 510(k) Number | K910221 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 17, 1991 |
| Decision Date | May 16, 1991 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DXC — Clamp, Vascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4450 |