Cleared Traditional

Pantheris System

K212047 · Avinger, Inc. · Cardiovascular
Nov 2021
Decision
139d
Days
Class 2
Risk

About This 510(k) Submission

K212047 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 November 16, 2021, 139 days after receiving the submission on June 30, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4875.

Submission Details

510(k) Number K212047 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 2021
Decision Date November 16, 2021
Days to Decision 139 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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