FDA.reportPublic FDA data

Wolverine Coronary Cutting Balloon

Primary DI
08714729888376
Brand
Wolverine Coronary Cutting Balloon
Company
BOSTON SCIENTIFIC CORPORATION
Model
H74939401153500
Catalog number
H74939401153500
Device description
Microsurgical Dilatation Device
Published
2017-11-22
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P950020072
P950020079
P950020112
P950020133
P950020141

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P950020072FLEXATOME CUTTING BALLOONBoston Scientific Corp2000-04-18NWX
P950020079FLEXATOME CUTTING BALLOONBoston Scientific Corp2000-04-18NWX
P950020112FLEXATOME CUTTING BALLOONBoston Scientific Corp2000-04-18NWX
P950020133FLEXATOME CUTTING BALLOONBoston Scientific Corp2000-04-18NWX
P950020141FLEXATOME CUTTING BALLOONBoston Scientific Corp2000-04-18NWX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729888376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729888376087147298883768714729888376

GMDN Terms#

Term, Definition table
TermDefinition
Coronary angioplasty balloon catheter, cutting/scoringA sterile, flexible tube designed for use in percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery and increase myocardial perfusion, by controlled inflation of a distensible balloon at its distal tip with peripheral cutting/scoring elements (e.g., microsurgical atherotomes) intended to remove stenotic material. The device is typically placed using a guidewire and guiding catheter, and its balloon is inflated by the infusion of liquid through it tubular body. The tube and balloon are typically made of polymer materials and the cutting/scoring elements are typically made of metal [e.g., nickel-titanium alloy (Nitinol)]. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191506021214AMS 700 LGX™ TENACIO™ Pump72404400724044002024-01-26
00191506021221AMS 700 LGX™ TENACIO™ Pump72404401724044012024-01-26
00191506021238AMS 700 LGX™ TENACIO™ Pump72404402724044022024-01-26
00191506021245AMS 700 LGX™ TENACIO™ Pump72404403724044032024-01-26
00191506021252AMS 700 LGX™ TENACIO™ Pump72404405724044052024-01-26
00191506021269AMS 700 LGX™ TENACIO™ Pump72404406724044062024-01-26
00191506021276AMS 700 LGX™ TENACIO™ Pump72404407724044072024-01-26
00191506021283AMS 700 LGX™ TENACIO™ Pump72404408724044082024-01-26
00191506021290AMS 700™ TENACIO™ Pump72404420724044202024-01-26
00191506021306AMS 700™ TENACIO™ Pump72404429724044292024-01-26
00191506021313AMS 700™ CX TENACIO™ Pump72404430724044302024-01-26
00191506021320AMS 700™ CX TENACIO™ Pump72404431724044312024-01-26
00191506021337AMS 700™ CX TENACIO™ Pump72404432724044322024-01-26
00191506021344AMS 700™ CX TENACIO™ Pump72404433724044332024-01-26
00191506021351AMS 700™ CX TENACIO™ Pump72404434724044342024-01-26
00191506021368AMS 700™ CX TENACIO™ Pump72404435724044352024-01-26
00191506021375AMS 700™ CX TENACIO™ Pump72404436724044362024-01-26
00191506021382AMS 700™ CX TENACIO™ Pump72404437724044372024-01-26
00191506021399AMS 700™ CX TENACIO™ Pump72404438724044382024-01-26
00191506021405AMS 700™ CX TENACIO™ Pump72404439724044392024-01-26

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