FDA.reportPublic FDA data

AngioSculpt® PTCA Scoring Balloon Catheter

Primary DI
M370202725151C
Brand
AngioSculpt® PTCA Scoring Balloon Catheter
Company
Angioscore Inc.
Model
2027-2515
Published
2017-02-12
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

Product Codes#

Code, Name table
CodeName
NWXCatheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWXCatheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/ScoringUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M370202725151CPrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Coronary angioplasty balloon catheter, basicA flexible tube designed for percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible balloon(s) at its distal tip. It is typically available as: 1) an over-the-wire (OTW) type that has a double or triple-lumen, one for the guidewire and one or two for single- or double-balloon inflation; and 2) a rapid exchange (RX) type with a single-lumen. It is available in various sizes for the dilatation of small, narrowed, or obstructed coronary arteries or bypass grafts. It may also be intended for pre- or post-dilatation of a balloon-expandable stent (not included) in the coronary arteries. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
615286726
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M370200120101AngioSculpt® PTCA Scoring Balloon Catheter2001-20102014-09-23
M370200120151AngioSculpt® PTCA Scoring Balloon Catheter2001-20152014-09-23
M370200120201AngioSculpt® PTCA Scoring Balloon Catheter2001-20202014-09-23
M370200125101AngioSculpt® PTCA Scoring Balloon Catheter2001-25102014-09-23
M3702001251514AngioSculpt® PTCA Scoring Balloon Catheter2001-25152014-09-23
M3702001252010AngioSculpt® PTCA Scoring Balloon Catheter2001-25202014-09-23
M370200130101AngioSculpt® PTCA Scoring Balloon Catheter2001-30102014-09-23
M3702001301510AngioSculpt® PTCA Scoring Balloon Catheter2001-30152014-09-23
M370200130201AngioSculpt® PTCA Scoring Balloon Catheter2001-30202014-09-23
M3702001351010AngioSculpt® PTCA Scoring Balloon Catheter2001-35102014-09-23
M3702001351515AngioSculpt® PTCA Scoring Balloon Catheter2001-35152014-09-23
M3702001352011AngioSculpt® PTCA Scoring Balloon Catheter2001-35202014-09-23
M3702027201012AngioSculpt® PTCA Scoring Balloon Catheter2027-20102014-09-23
M3702027201517AngioSculpt® PTCA Scoring Balloon Catheter2027-20152014-09-23
M3702027202013AngioSculpt® PTCA Scoring Balloon Catheter2027-20202014-09-23
M3702027251017AngioSculpt® PTCA Scoring Balloon Catheter2027-25102014-09-23
M3702027252018AngioSculpt® PTCA Scoring Balloon Catheter2027-25202014-09-23
M3702027301013AngioSculpt® PTCA Scoring Balloon Catheter2027-30102014-09-23
M3702027301518AngioSculpt® PTCA Scoring Balloon Catheter2027-30152014-09-23
M3702027302014AngioSculpt® PTCA Scoring Balloon Catheter2027-30202014-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06934955936258Scoreflex NC Scoring PTCA CatheterOrbusNeich Medical (ShenZhen) Co., Ltd.NWX2022-02-17
06934955936265Scoreflex NC Scoring PTCA CatheterOrbusNeich Medical (ShenZhen) Co., Ltd.NWX2022-02-17
06934955936272Scoreflex NC Scoring PTCA CatheterOrbusNeich Medical (ShenZhen) Co., Ltd.NWX2022-02-16
06934955936289Scoreflex NC Scoring PTCA CatheterOrbusNeich Medical (ShenZhen) Co., Ltd.NWX2022-02-16
06934955936296Scoreflex NC Scoring PTCA CatheterOrbusNeich Medical (ShenZhen) Co., Ltd.NWX2022-02-16
06934955936302Scoreflex NC Scoring PTCA CatheterOrbusNeich Medical (ShenZhen) Co., Ltd.NWX2022-02-16
06934955936319Scoreflex NC Scoring PTCA CatheterOrbusNeich Medical (ShenZhen) Co., Ltd.NWX2022-02-16
06934955936326Scoreflex NC Scoring PTCA CatheterOrbusNeich Medical (ShenZhen) Co., Ltd.NWX2022-02-16
06934955936333Scoreflex NC Scoring PTCA CatheterOrbusNeich Medical (ShenZhen) Co., Ltd.NWX2022-02-16
06934955936340Scoreflex NC Scoring PTCA CatheterOrbusNeich Medical (ShenZhen) Co., Ltd.NWX2022-02-16
06934955936357Scoreflex NC Scoring PTCA CatheterOrbusNeich Medical (ShenZhen) Co., Ltd.NWX2022-02-16
06934955936364Scoreflex NC Scoring PTCA CatheterOrbusNeich Medical (ShenZhen) Co., Ltd.NWX2022-02-16
06934955936371Scoreflex NC Scoring PTCA CatheterOrbusNeich Medical (ShenZhen) Co., Ltd.NWX2022-02-16
06934955936388Scoreflex NC Scoring PTCA CatheterOrbusNeich Medical (ShenZhen) Co., Ltd.NWX2022-02-16
06934955936395Scoreflex NC Scoring PTCA CatheterOrbusNeich Medical (ShenZhen) Co., Ltd.NWX2022-02-16
06934955936401Scoreflex NC Scoring PTCA CatheterOrbusNeich Medical (ShenZhen) Co., Ltd.NWX2022-02-16
06934955936418Scoreflex NC Scoring PTCA CatheterOrbusNeich Medical (ShenZhen) Co., Ltd.NWX2022-02-16
06934955936425Scoreflex NC Scoring PTCA CatheterOrbusNeich Medical (ShenZhen) Co., Ltd.NWX2022-02-16
06934955936432Scoreflex NC Scoring PTCA CatheterOrbusNeich Medical (ShenZhen) Co., Ltd.NWX2022-02-16
06934955936449Scoreflex NC Scoring PTCA CatheterOrbusNeich Medical (ShenZhen) Co., Ltd.NWX2022-02-16
06934955936456Scoreflex NC Scoring PTCA CatheterOrbusNeich Medical (ShenZhen) Co., Ltd.NWX2022-02-16
06934955936463Scoreflex NC Scoring PTCA CatheterOrbusNeich Medical (ShenZhen) Co., Ltd.NWX2022-02-16
06934955936470Scoreflex NC Scoring PTCA CatheterOrbusNeich Medical (ShenZhen) Co., Ltd.NWX2022-02-16
06934955936487Scoreflex NC Scoring PTCA CatheterOrbusNeich Medical (ShenZhen) Co., Ltd.NWX2022-02-16
00813132026790AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coatingPhilips Image Guided Therapy CorporationNWX2020-09-29
00813132026806AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coatingPhilips Image Guided Therapy CorporationNWX2020-09-29
00813132026813AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coatingPhilips Image Guided Therapy CorporationNWX2020-09-29
00813132026820AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coatingPhilips Image Guided Therapy CorporationNWX2020-09-29
00813132026837AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coatingPhilips Image Guided Therapy CorporationNWX2020-09-29
00813132026844AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coatingPhilips Image Guided Therapy CorporationNWX2020-09-29