K241230 is an FDA 510(k) clearance for the Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Togo Medikit Co., Ltd. (Miyazaki, JP). The FDA issued a Cleared decision on September 17, 2024, 138 days after receiving the submission on May 2, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K241230 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 2024 |
| Decision Date | September 17, 2024 |
| Days to Decision | 138 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 |