Cleared Traditional

Pantheris System

K173862 · Avinger, Inc. · Cardiovascular
May 2018
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K173862 is an FDA 510(k) clearance for the Pantheris System, 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 May 22, 2018, 153 days after receiving the submission on December 20, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4875.

Submission Details

510(k) Number K173862 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2017
Decision Date May 22, 2018
Days to Decision 153 days
Submission Type Traditional
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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