FDA.reportPublic FDA data

Phoenix Handle

Primary DI
00845225002664
Brand
Phoenix Handle
Company
VOLCANO ATHEROMED, INC.
Model
P00633
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MCWCatheter, Peripheral, Atherectomy

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845225002664PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845225002664008452250026648452250026640845225002664

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
788341084
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845225003104QuickClear Thrombectomy SystemAC8ST085AC8ST0852022-01-19
00845225003005QuickClear Aspiration PumpP3223ASPP3223ASP2020-06-11
00845225003012QuickClear Aspiration PumpP3223P32232020-06-11
00845225003081QuickClear Thrombectomy SystemAC6ST130AC6ST1302020-06-11
00845225003128QuickClear Thrombectomy SystemAC8SH085AC8SH0852020-06-11
00845225003142QuickClear Thrombectomy SystemAC10SH085AC10SH0852020-06-11
00845225003180Phoenix 2.4mm x 130cm 7F Deflecting Atherectomy CatheterPD24130PD241302021-10-26
00845225003197Phoenix 2.4mm x 130cm 7F Deflecting Atherectomy SystemPD24130KPD24130K2021-10-26
00845225002985Phoenix 2.2mm x 130cm 6F Deflecting Atherectomy CatheterPD22130PD221302019-03-07
00845225002992Phoenix 2.2mm x 130cm 6F Deflecting Atherectomy SystemPD22130K PD22130K2019-03-07
00845225003166Phoenix 1.5mm x 149cm 4F Atherectomy CatheterP15149P151492021-10-26
00845225003173Phoenix 1.5mm x 149cm 4F Atherectomy SystemP15149KP15149K2021-10-26
00845225002619Phoenix 1.8mm x 130cm 5F Atherectomy CatheterP18130P181302016-09-01
00845225002626Phoenix 2.2mm x 130cm 6F Atherectomy CatheterP22130P221302016-09-01
00845225002633Phoenix 2.4mm 7F Deflecting Atherectomy CatheterPD24127PD241272016-09-01
00845225002640Phoenix 1.8mm x 149cm 5F Atherectomy CatheterP18149P181492016-09-01
00845225002657Phoenix 2.2mm x 149cm 6F Atherectomy CatheterP22149P221492016-09-01
00845225002695Phoenix 1.8mm x 130cm 5F Atherectomy SystemP18130KP18130K2016-09-01
00845225002701Phoenix 2.2mm x 130cm 6F Atherectomy SystemP22130KP22130K2016-09-01
00845225002718Phoenix 2.4mm 7F Deflecting Atherectomy SystemPD24127KPD24127K2016-09-01

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