Cleared Traditional

MICROSLIDER TEARAWAY INTRODUCER SET

K123430 · Galt Medical Corp. · Cardiovascular
Apr 2013
Decision
156d
Days
Class 2
Risk

About This 510(k) Submission

K123430 is an FDA 510(k) clearance for the MICROSLIDER TEARAWAY INTRODUCER SET, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Galt Medical Corp. (Garland, US). The FDA issued a Cleared decision on April 12, 2013, 156 days after receiving the submission on November 7, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K123430 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 2012
Decision Date April 12, 2013
Days to Decision 156 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