Cleared Traditional

FLIP INTRODUCER ACCESS KIT

K132789 · Vascular Solutions, Inc. · Cardiovascular
Apr 2014
Decision
223d
Days
Class 2
Risk

About This 510(k) Submission

K132789 is an FDA 510(k) clearance for the FLIP INTRODUCER ACCESS KIT, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Vascular Solutions, Inc. (Maple Grove, US). The FDA issued a Cleared decision on April 17, 2014, 223 days after receiving the submission on September 6, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K132789 FDA.gov
FDA Decision Cleared SESE
Date Received September 06, 2013
Decision Date April 17, 2014
Days to Decision 223 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