K231227 is an FDA 510(k) clearance for the SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Baylis Medical Company, Inc. (Mississauga, CA). The FDA issued a Cleared decision on December 20, 2023, 236 days after receiving the submission on April 28, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K231227 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 28, 2023 |
| Decision Date | December 20, 2023 |
| Days to Decision | 236 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 |