Cleared Special

WILDCAT 5F GUIDEWIRE SUPPORT CATHETER

K112579 · Avinger, Inc. · Cardiovascular
Oct 2011
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K112579 is an FDA 510(k) clearance for the WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Avinger, Inc. (Redwood City, US). The FDA issued a Cleared decision on October 6, 2011, 30 days after receiving the submission on September 6, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K112579 FDA.gov
FDA Decision Cleared SESE
Date Received September 06, 2011
Decision Date October 06, 2011
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQY — Catheter, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

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