Cleared Special

Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled

K172236 · Avinger, Inc. · Cardiovascular
Oct 2017
Decision
97d
Days
Class 2
Risk

About This 510(k) Submission

K172236 is an FDA 510(k) clearance for the Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled, a Catheter, Peripheral, Atherectomy (Class II — Special Controls, product code MCW), submitted by Avinger, Inc. (Redwood City, US). The FDA issued a Cleared decision on October 30, 2017, 97 days after receiving the submission on July 25, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4875.

Submission Details

510(k) Number K172236 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 2017
Decision Date October 30, 2017
Days to Decision 97 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MCW — Catheter, Peripheral, Atherectomy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4875

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