Cleared Traditional

AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX

K111704 · Avinger, Inc. · Cardiovascular
Sep 2011
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K111704 is an FDA 510(k) clearance for the AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Avinger, Inc. (Redwood City, US). The FDA issued a Cleared decision on September 9, 2011, 84 days after receiving the submission on June 17, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K111704 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 2011
Decision Date September 09, 2011
Days to Decision 84 days
Submission Type Traditional
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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