K153533 is an FDA 510(k) clearance for the Tearaway Introducer Sheath, MicroSlide Tearaway Introducer. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Galt Medical Corp. (Garland, US). The FDA issued a Cleared decision on July 5, 2016, 209 days after receiving the submission on December 9, 2015.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K153533 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 2015 |
| Decision Date | July 05, 2016 |
| Days to Decision | 209 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 |