K210185 is an FDA 510(k) clearance for the CardioCurve Steerable Sheath. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Talon Surgical (Salt Lake City, US). The FDA issued a Cleared decision on July 23, 2021, 179 days after receiving the submission on January 25, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K210185 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 25, 2021 |
| Decision Date | July 23, 2021 |
| Days to Decision | 179 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 |