Cleared Traditional

K142829 - Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification (FDA 510(k) Clearance)

Also includes:

Flexor Check-Flo Introducer, Ansel Modification Flexor Check-Flo Introducers, Ansel Modification with High-Flex Dilator and Hydrophilic Coating Flexor Check-Flo Introducer Balkin Up and Over Contralateral Design Flexor Up and Over Balkin Contralateral Introducer Flexor Check-Flo Introducer, Raabe Modification Flexor Check-Flo Performer Introducer

K142829 · Cook Incorporated · Cardiovascular device

Jul 2015

Decision

301d

Days

Class 2

Risk

K142829 is an FDA 510(k) clearance for the Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on July 28, 2015, 301 days after receiving the submission on September 30, 2014.

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

Submission Details

510(k) Number	K142829 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 30, 2014
Decision Date	July 28, 2015
Days to Decision	301 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF