Cleared Special

VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING

K040786 · Neometrics, Inc. · Cardiovascular
Apr 2004
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K040786 is an FDA 510(k) clearance for the VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Neometrics, Inc. (Plymouth, US). The FDA issued a Cleared decision on April 19, 2004, 21 days after receiving the submission on March 29, 2004. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K040786 FDA.gov
FDA Decision Cleared SESE
Date Received March 29, 2004
Decision Date April 19, 2004
Days to Decision 21 days
Submission Type Special
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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