FDA.reportPublic FDA data

FreedomFlow Orbital Circumferential Atherectomy System

Primary DI
00850040691054
Brand
FreedomFlow Orbital Circumferential Atherectomy System
Company
Cardio Flow, Inc.
Model
H6002
Device description
FreedomFlow Orbital Circumferential Atherectomy System Electric User Handle, 6Fr 135 cm, 5-sphere
Published
2024-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MCWCatheter, Peripheral, Atherectomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCWCatheter, Peripheral, AtherectomyCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231538000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231538000FreedomFlow Orbital Circumferential Atherectomy SystemCardio Flow Inc.,2023-09-27MCW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
90850040691064PackageGS15In Commercial Distribution
00850040691054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
9085004069106490850040691064
00850040691054008500406910548500406910540850040691054

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical atherectomy system catheter, peripheralA sterile, flexible tube (catheter) intended to be percutaneously introduced for the intraluminal mechanical disruption of atheroma plaque from the walls of peripheral arteries. It has a power-driven cutting or abrasive head for slicing/grinding the atheroma into fragments small enough to be aspirated or absorbed. This device is not intended for use in the coronary, carotid, iliac or renal vasculature. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Atherectomy Rotating Component2Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity50 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
800-294-5517customerservice@cardioflow.net

Regulatory Flags#

DUNS number
080505958
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850040691009Cardio Flow Peripheral Guide WireGW10012024-06-21
00850040691023Cardio Flow Peripheral Guide WireGW10012024-06-21
00850040691030FreedomFlow Orbital Circumferential Atherectomy SystemH60012024-06-21
00850040691085FreedomFlow Orbital Circumferential Atherectomy SystemH60042024-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290017590264AuryonEXIMO MEDICAL LTDMCW2026-06-02
06975417183858PantherisZylox-Tonbridge Medical Technology Co., Ltd.MCW2026-03-21
06975417183865PantherisZylox-Tonbridge Medical Technology Co., Ltd.MCW2026-03-21
06975417183872PantherisZylox-Tonbridge Medical Technology Co., Ltd.MCW2026-03-21
06975417183889PantherisZylox-Tonbridge Medical Technology Co., Ltd.MCW2026-03-21
00857141005322Revolution Peripheral Atherectomy SystemRex Medical, Inc.MCW2025-12-16
00857141005339Revolution Peripheral Atherectomy SystemRex Medical, Inc.MCW2025-12-16
00857141005346Revolution Peripheral Atherectomy SystemRex Medical, Inc.MCW2025-12-16
00857141005377Revolution Peripheral Atherectomy SystemRex Medical, Inc.MCW2025-12-16
00857141005384Revolution Peripheral Atherectomy SystemRex Medical, Inc.MCW2025-12-16
00857141005391Revolution Peripheral Atherectomy SystemRex Medical, Inc.MCW2025-12-16
00857141005407Revolution Peripheral Atherectomy SystemRex Medical, Inc.MCW2025-12-16
00857141005414Revolution Peripheral Atherectomy SystemRex Medical, Inc.MCW2025-12-16
00810060550793Turbo-Power Laser Atherectomy CatheterPhilips Image Guided Therapy CorporationMCW2025-10-21
00810060550809Turbo-Power Laser Atherectomy CatheterPhilips Image Guided Therapy CorporationMCW2025-10-21
00763000835392HawkOne™MEDTRONIC, INC.MCW2024-12-28
07290017590325Auryon Atherectomy CatheterEXIMO MEDICAL LTDMCW2024-09-16
07290017590332Auryon Atherectomy CatheterEXIMO MEDICAL LTDMCW2024-09-16
00763000918934TurboHawk™MEDTRONIC, INC.MCW2024-08-18
00763000918941TurboHawk™MEDTRONIC, INC.MCW2024-08-18
00763000918958TurboHawk™MEDTRONIC, INC.MCW2024-08-18
00763000918910SilverHawk™MEDTRONIC, INC.MCW2024-08-10
00763000918927SilverHawk™MEDTRONIC, INC.MCW2024-08-10
00763000918965Cutter DriverMEDTRONIC, INC.MCW2024-08-10
00845225003463Phoenix 1.5mm x 149cm 4F Atherectomy CatheterPhilips Image Guided Therapy CorporationMCW2024-07-08
00845225003470Phoenix 1.8mm x 130cm 5F Atherectomy CatheterPhilips Image Guided Therapy CorporationMCW2024-07-08
00845225003487Phoenix 1.8mm x 149cm 5F Atherectomy CatheterPhilips Image Guided Therapy CorporationMCW2024-07-08
00845225003494Phoenix 2.2mm x 130cm 6F Atherectomy CatheterPhilips Image Guided Therapy CorporationMCW2024-07-08
00845225003500Phoenix 2.2mm x 149cm 6F Atherectomy CatheterPhilips Image Guided Therapy CorporationMCW2024-07-08
00845225003517Phoenix 2.2mm x 130cm 6F Pre-Deflected Atherectomy CatheterPhilips Image Guided Therapy CorporationMCW2024-07-08