Cleared Traditional

Pantheris SV

K182341 · Avinger, Inc. · Cardiovascular
Apr 2019
Decision
224d
Days
Class 2
Risk

About This 510(k) Submission

K182341 is an FDA 510(k) clearance for the Pantheris SV, 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 9, 2019, 224 days after receiving the submission on August 28, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4875.

Submission Details

510(k) Number K182341 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 2018
Decision Date April 09, 2019
Days to Decision 224 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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