Cleared Special

WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S

K102022 · Avinger, Inc. · Cardiovascular
Aug 2010
Decision
18d
Days
Class 2
Risk

About This 510(k) Submission

K102022 is an FDA 510(k) clearance for the WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Avinger, Inc. (Redwood City, US). The FDA issued a Cleared decision on August 6, 2010, 18 days after receiving the submission on July 19, 2010. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K102022 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 2010
Decision Date August 06, 2010
Days to Decision 18 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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