Cleared Traditional

Pantheris System

K152275 · Avinger, Inc. · Cardiovascular
Oct 2015
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K152275 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 October 14, 2015, 63 days after receiving the submission on August 12, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4875.

Submission Details

510(k) Number K152275 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 2015
Decision Date October 14, 2015
Days to Decision 63 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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