Cleared Special

FreedomFlow? Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)

K250723 · Cardio Flow Inc., · Cardiovascular
Apr 2025
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K250723 is an FDA 510(k) clearance for the FreedomFlow? Orbital Circumferential Atherectomy System (H6005/ 4Fr 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 April 25, 2025, 46 days after receiving the submission on March 10, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4875.

Submission Details

510(k) Number K250723 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 2025
Decision Date April 25, 2025
Days to Decision 46 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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