FDA.reportPublic FDA data

Turbo-Power Laser Atherectomy Catheter

Primary DI
00810060550809
Brand
Turbo-Power Laser Atherectomy Catheter
Company
Philips Image Guided Therapy Corporation
Model
423-050
Catalog number
423-050
Device description
Turbo-Power Laser Atherectomy Catheter, 2.3mm
Published
2025-10-21
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
K222837000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222837000Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy CathetersSpectranetics, Inc.2022-12-08MCW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810060550809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810060550809008100605508098100605508090810060550809

GMDN Terms#

Term, Definition table
TermDefinition
Atherectomy laser system beam guide-catheter, peripheralA sterile, flexible tube intended to be connected to an atherectomy laser system to invasively direct and deliver laser energy into the peripheral vasculature for the intraluminal photoablation or debulking of lesion material (blockages or total occlusions), to re-establish blood flow within the vessel. It typically consists of fibreoptic materials with a laser-firing distal end and may be designed for over-the-wire (OTW) or rapid exchange insertion. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Working Length125Centimeter
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry
Storage Environment Atmospheric Pressure11 KiloPascal111 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature32 Degrees Fahrenheit140 Degrees Fahrenheit

Contacts#

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

Regulatory Flags#

DUNS number
118354223
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813132029326Quick-Cross Support Catheter518-032518-0322022-02-22
00813132029333Quick-Cross Support Catheter518-033518-0332022-02-22
00813132029340Quick-Cross Support Catheter518-034518-0342022-02-22
00813132029357Quick-Cross Support Catheter518-035518-0352022-02-22
00813132029364Quick-Cross Support Catheter518-036518-0362022-02-22
00813132029371Quick-Cross Support Catheter518-037518-0372022-02-22
00813132029388Quick-Cross Support Catheter518-038518-0382022-02-22
00813132029395Quick-Cross Support Catheter518-065518-0652022-02-22
00813132029401Quick-Cross Support Catheter518-066518-0662022-02-22
00813132029418Quick-Cross Extreme Support Catheter518-084518-0842023-10-04
00813132029425Quick-Cross Extreme Support Catheter518-086518-0862023-10-04
00813132029432Quick-Cross Extreme Support Catheter518-088518-0882023-10-04
00813132029449Quick-Cross Extreme Support Catheter518-090518-0902023-10-04
00813132029456Quick-Cross Extreme Support Catheter518-092518-0922023-10-04
00813132029470Quick-Cross Extreme Support Catheter518-078518-0782023-10-04
00813132029487Quick-Cross Extreme Support Catheter518-080518-0802023-10-04
00813132029494Quick-Cross Extreme Support Catheter518-082518-0822023-10-04
00813132029517Quick-Cross Select Support Catheter518-085518-0852023-10-04
00813132029524Quick-Cross Select Support Catheter518-087518-0872023-10-04
00813132029531Quick-Cross Select Support Catheter518-089518-0892023-10-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885403530596FogartyBecton, Dickinson And CompanyMCW2026-09-04
00885403530602FogartyBecton, Dickinson And CompanyMCW2026-09-04
07290017590356AuryonEXIMO MEDICAL LTDMCW2026-08-27
07290017590370AuryonEXIMO MEDICAL LTDMCW2026-08-27
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
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