Cleared Special

Pantheris Catheter

K160827 · Avinger, Inc. · Cardiovascular
Apr 2016
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K160827 is an FDA 510(k) clearance for the Pantheris Catheter, 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 April 21, 2016, 27 days after receiving the submission on March 25, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4875.

Submission Details

510(k) Number K160827 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 2016
Decision Date April 21, 2016
Days to Decision 27 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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