K121504 is an FDA 510(k) clearance for the SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Togo Medikit Co., Ltd. (Austin, US). The FDA issued a Cleared decision on September 27, 2012, 129 days after receiving the submission on May 21, 2012.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K121504 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 21, 2012 |
| Decision Date | September 27, 2012 |
| Days to Decision | 129 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 |