Cleared Traditional

K142051 - PRELUDE PLASTIC JACKETED GUIDE WIRE (FDA 510(k) Clearance)

K142051 · Merit Medical Systems, Inc. · Cardiovascular device

Dec 2014

Decision

142d

Days

Class 2

Risk

K142051 is an FDA 510(k) clearance for the PRELUDE PLASTIC JACKETED GUIDE WIRE. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).

Submitted by Merit Medical Systems, Inc. (Galway, IE). The FDA issued a Cleared decision on December 17, 2014, 142 days after receiving the submission on July 28, 2014.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number	K142051 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 28, 2014
Decision Date	December 17, 2014
Days to Decision	142 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF