K231412 is an FDA 510(k) clearance for the CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S). This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Biosense Webster, Inc. (Irvine, US). The FDA issued a Cleared decision on July 10, 2023, 55 days after receiving the submission on May 16, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K231412 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 2023 |
| Decision Date | July 10, 2023 |
| Days to Decision | 55 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DYB — Introducer, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1340 |