Cleared Traditional

VASCUPUNCTURE PICC GUIDEWIRE

K031652 · Neometrics, Inc. · Cardiovascular
Sep 2003
Decision
125d
Days
Class 2
Risk

About This 510(k) Submission

K031652 is an FDA 510(k) clearance for the VASCUPUNCTURE PICC GUIDEWIRE, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Neometrics, Inc. (Plymouth, US). The FDA issued a Cleared decision on September 30, 2003, 125 days after receiving the submission on May 28, 2003. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K031652 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 2003
Decision Date September 30, 2003
Days to Decision 125 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQX — Wire, Guide, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1330

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