Cleared Traditional

Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled

K162326 · Avinger, Inc. · Cardiovascular
Oct 2016
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K162326 is an FDA 510(k) clearance for the Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled, 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 18, 2016, 60 days after receiving the submission on August 19, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4875.

Submission Details

510(k) Number K162326 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 2016
Decision Date October 18, 2016
Days to Decision 60 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

Similar Devices — MCW Catheter, Peripheral, Atherectomy

All 144
FreedomFlow? Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)
K250723 · Cardio Flow Inc., · Apr 2025
Turbo-Elite Laser Atherectomy Catheter
K250385 · Spectranetics · Mar 2025
Rotarex Atherectomy System
K242757 · Bard Peripheral Vascular, Inc. · Jan 2025
FreedomFlow? Orbital Circumferential Atherectomy System
K242947 · Cardio Flow Inc., · Nov 2024
Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating
K241553 · Eximo Medical, Ltd. · Jun 2024
FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)
K233483 · Cardio Flow Inc., · Feb 2024