Cleared Special

INTRAVASCULAR INTRODUCER SYSTEM

K063658 · Applied Medical Resources Corp. · Cardiovascular
Sep 2007
Decision
278d
Days
Class 2
Risk

About This 510(k) Submission

K063658 is an FDA 510(k) clearance for the INTRAVASCULAR INTRODUCER SYSTEM, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Applied Medical Resources Corp. (Rancho Santa, US). The FDA issued a Cleared decision on September 12, 2007, 278 days after receiving the submission on December 8, 2006. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K063658 FDA.gov
FDA Decision Cleared SESE
Date Received December 08, 2006
Decision Date September 12, 2007
Days to Decision 278 days
Submission Type Special
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