Cleared Traditional

2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER

K130687 · Medical Components, Inc. · Cardiovascular
Aug 2013
Decision
155d
Days
Class 2
Risk

About This 510(k) Submission

K130687 is an FDA 510(k) clearance for the 2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Medical Components, Inc. (Harleysville, US). The FDA issued a Cleared decision on August 15, 2013, 155 days after receiving the submission on March 13, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K130687 FDA.gov
FDA Decision Cleared SESE
Date Received March 13, 2013
Decision Date August 15, 2013
Days to Decision 155 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