Cleared Traditional

VALVED TEARAWAY INTRODUCER GENERATION II

K124046 · Medical Components, Inc. · Cardiovascular
Jun 2013
Decision
154d
Days
Class 2
Risk

About This 510(k) Submission

K124046 is an FDA 510(k) clearance for the VALVED TEARAWAY INTRODUCER GENERATION II, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Medical Components, Inc. (Harleysville, US). The FDA issued a Cleared decision on June 3, 2013, 154 days after receiving the submission on December 31, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K124046 FDA.gov
FDA Decision Cleared SESE
Date Received December 31, 2012
Decision Date June 03, 2013
Days to Decision 154 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