Cleared Special

FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)

K233483 · Cardio Flow Inc., · Cardiovascular
Feb 2024
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K233483 is an FDA 510(k) clearance for the FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration), 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 February 15, 2024, 111 days after receiving the submission on October 27, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4875.

Submission Details

510(k) Number K233483 FDA.gov
FDA Decision Cleared SESE
Date Received October 27, 2023
Decision Date February 15, 2024
Days to Decision 111 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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