K112407 is an FDA 510(k) clearance for the SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Smiths Medical MD, Inc. (St. Paul, US). The FDA issued a Cleared decision on February 9, 2012, 171 days after receiving the submission on August 22, 2011.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K112407 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 2011 |
| Decision Date | February 09, 2012 |
| Days to Decision | 171 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 |