K213531 is an FDA 510(k) clearance for the TR BAND Radial Compression Device. This device is classified as a Clamp, Vascular (Class II - Special Controls, product code DXC).
Submitted by Terumo Medical Corporation (Elkton, US). The FDA issued a Cleared decision on December 20, 2021, 45 days after receiving the submission on November 5, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4450.
| 510(k) Number | K213531 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 2021 |
| Decision Date | December 20, 2021 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXC — Clamp, Vascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4450 |