Cleared Traditional

Pantheris LV Atherectomy Catheter

K230005 · Avinger, Inc. · Cardiovascular
Jun 2023
Decision
154d
Days
Class 2
Risk

About This 510(k) Submission

K230005 is an FDA 510(k) clearance for the Pantheris LV Atherectomy 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 June 6, 2023, 154 days after receiving the submission on January 3, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4875.

Submission Details

510(k) Number K230005 FDA.gov
FDA Decision Cleared SESE
Date Received January 03, 2023
Decision Date June 06, 2023
Days to Decision 154 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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