Cleared Traditional

K131148 - THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH (FDA 510(k) Clearance)

K131148 · Access Scientific, LLC · Cardiovascular device

Sep 2013

Decision

134d

Days

Class 2

Risk

K131148 is an FDA 510(k) clearance for the THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).

Submitted by Access Scientific, LLC (San Diego, US). The FDA issued a Cleared decision on September 4, 2013, 134 days after receiving the submission on April 23, 2013.

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

Submission Details

510(k) Number	K131148 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 23, 2013
Decision Date	September 04, 2013
Days to Decision	134 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF