Cleared Traditional

K132592 - FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET
(FDA 510(k) Clearance)

K132592 · Cook, Inc. · Cardiovascular
Oct 2014
Decision
416d
Days
Class 2
Risk

K132592 is an FDA 510(k) clearance for the FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET. This device is classified as a Introducer, Catheter (Class II — Special Controls, product code DYB).

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on October 9, 2014, 416 days after receiving the submission on August 19, 2013.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K132592 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 2013
Decision Date October 09, 2014
Days to Decision 416 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