Cleared Traditional

NEOWIRE PTA/PTCA GUIDEWIRE

K101729 · Neometrics, Inc. · Cardiovascular
Sep 2010
Decision
94d
Days
Class 2
Risk

About This 510(k) Submission

K101729 is an FDA 510(k) clearance for the NEOWIRE PTA/PTCA 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 23, 2010, 94 days after receiving the submission on June 21, 2010. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K101729 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 2010
Decision Date September 23, 2010
Days to Decision 94 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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