FDA.reportPublic FDA data

Phoenix 1.8mm x 130cm 5F Atherectomy Catheter

Primary DI
00845225002619
Brand
Phoenix 1.8mm x 130cm 5F Atherectomy Catheter
Company
Volcano Atheromed, Inc.
Model
P18130
Catalog number
P18130
Published
2016-09-01
Public version status
Update
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845225002619PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845225002619008452250026198452250026190845225002619

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
Length130Centimeter
Outer Diameter1.8Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800) 228-4728IGTD.CustomerInquiry@philips.com

Regulatory Flags#

DUNS number
788341084
Device count
1
Lot or batch
true
Expiration date on label
true

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
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
00845225002725Phoenix 1.8mm x 149cm 5F Atherectomy SystemP18149KP18149K2016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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07290017590325Auryon Atherectomy CatheterEXIMO MEDICAL LTDMCW2024-09-16
07290017590332Auryon Atherectomy CatheterEXIMO MEDICAL LTDMCW2024-09-16
00763000918934TurboHawk™MEDTRONIC, INC.MCW2024-08-18
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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
00845225003524Phoenix 2.4mm x 130cm 7F Pre-Deflected Atherectomy CatheterPhilips Image Guided Therapy CorporationMCW2024-07-08