Cleared Traditional

PERCUTANEOUS INTRODUCER KIT

K123974 · Teleflex, Inc. · Cardiovascular
Feb 2013
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K123974 is an FDA 510(k) clearance for the PERCUTANEOUS INTRODUCER KIT, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Teleflex, Inc. (Jaffrey, US). The FDA issued a Cleared decision on February 21, 2013, 57 days after receiving the submission on December 26, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K123974 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 2012
Decision Date February 21, 2013
Days to Decision 57 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