Cleared Special

FreedomFlow? Orbital Circumferential Atherectomy System

K242947 · Cardio Flow Inc., · Cardiovascular
Nov 2024
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K242947 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 November 5, 2024, 41 days after receiving the submission on September 25, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4875.

Submission Details

510(k) Number K242947 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 2024
Decision Date November 05, 2024
Days to Decision 41 days
Submission Type Special
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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