Cleared Traditional

K231538 - FreedomFlow Orbital Circumferential Ath...

K231538 is an FDA 510(k) clearance for FreedomFlow Orbital Circumferential Ath..., manufactured by Cardio Flow Inc.,. The device is a Class 2 Cardiovascular device with product code MCW cleared through the Traditional 510(k) pathway after a 120-day FDA review.

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

K231538 is an FDA 510(k) clearance for the FreedomFlow Orbital Circumferential Atherectomy System. Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Cardio Flow Inc., (Blaine, US). The FDA issued a Cleared decision on September 27, 2023 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4875 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Cardio Flow Inc., devices

FDA 510(k) Submission Details - K231538

510(k) Number K231538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 125d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MCW Device Classification - Class 2, Special Controls

Product Code MCW Catheter, Peripheral, Atherectomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4875
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MCW Catheter, Peripheral, Atherectomy

All 75
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K231538.
Auryon Atherectomy Catheter 1.7mm
K241553 · Eximo Medical, Ltd. · Jun 2024
FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)
K233483 · Cardio Flow Inc., · Feb 2024
Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000)
K233668 · Eximo Medical, Ltd. · Dec 2023
Auryon Atherectomy System
K230709 · Eximo Medical, Ltd. · Jun 2023
Pantheris LV Atherectomy Catheter
K230005 · Avinger, Inc. · Jun 2023
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
K222837 · Spectranetics, Inc. · Dec 2022