Cleared Traditional

VASCUPUNCTURE ACCESS WIRE

K012861 · Neometrics, Inc. · Cardiovascular
Feb 2002
Decision
165d
Days
Class 2
Risk

About This 510(k) Submission

K012861 is an FDA 510(k) clearance for the VASCUPUNCTURE ACCESS WIRE, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Neometrics, Inc. (Minneapolis, US). The FDA issued a Cleared decision on February 5, 2002, 165 days after receiving the submission on August 24, 2001. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K012861 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 2001
Decision Date February 05, 2002
Days to Decision 165 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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