Cleared Traditional

SELECTIVA GUIDEWIRE

K013024 · Neometrics, Inc. · Cardiovascular
Dec 2001
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K013024 is an FDA 510(k) clearance for the SELECTIVA GUIDEWIRE, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Neometrics, Inc. (Minneapolis, US). The FDA issued a Cleared decision on December 4, 2001, 88 days after receiving the submission on September 7, 2001. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K013024 FDA.gov
FDA Decision Cleared SESE
Date Received September 07, 2001
Decision Date December 04, 2001
Days to Decision 88 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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