K173287 is an FDA 510(k) clearance for the Elite HV Radial. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Galt Medical Corp. (Garland, US). The FDA issued a Cleared decision on December 21, 2017, 66 days after receiving the submission on October 16, 2017.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K173287 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | October 16, 2017 |
| Decision Date | December 21, 2017 |
| Days to Decision | 66 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DYB - Introducer, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1340 |