Cleared Traditional

FreedomFlow Orbital Circumferential Atherectomy System

K231538 · Cardio Flow Inc., · Cardiovascular
Sep 2023
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K231538 is an FDA 510(k) clearance for the FreedomFlow Orbital Circumferential Atherectomy System, a Catheter, Peripheral, Atherectomy (Class II — Special Controls, product code MCW), submitted by Cardio Flow Inc., (Blaine, US). The FDA issued a Cleared decision on September 27, 2023, 120 days after receiving the submission on May 30, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4875.

Submission Details

510(k) Number K231538 FDA.gov
FDA Decision Cleared SESE
Date Received May 30, 2023
Decision Date September 27, 2023
Days to Decision 120 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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