Cleared Traditional

Tearaway Introducer Sheath, MicroSlide Tearaway Introducer

K153533 · Galt Medical Corp. · Cardiovascular
Jul 2016
Decision
209d
Days
Class 2
Risk

About This 510(k) Submission

K153533 is an FDA 510(k) clearance for the Tearaway Introducer Sheath, MicroSlide Tearaway Introducer, 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 review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K153533 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code DYB — Introducer, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1340