FDA.reportPublic FDA data

AngioSculpt®PTCA Scoring Balloon Catheter

Primary DI
00813132021047
Brand
AngioSculpt®PTCA Scoring Balloon Catheter
Company
Spectranetics Corporation
Model
2027-2510
Catalog number
2027-2510
Device description
AngioSculpt® PTCA Scoring Balloon Catheter
Published
2015-03-09
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
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
00813132021047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813132021047008131320210478131320210470813132021047

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
Length10Millimeter
Outer Diameter2.5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry
Storage Environment Temperature0 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
1-800-633-0960SPNC-complaints@philips.com

Regulatory Flags#

DUNS number
151047370
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813132020293SLS II Laser Sheath500-001500-0012015-02-06
00813132020309SLS II Laser Sheath500-012500-0122015-02-06
00813132020316SLS II Laser Sheath500-013500-0132015-02-06
00813132020903SightRail Manual Dilator Sheath550-008550-0082015-02-06
00813132020910SightRail Manual Dilator Sheath550-010550-0102015-02-06
00813132020927SightRail Manual Dilator Sheath550-011550-0112015-02-06
00813132020934SightRail Manual Dilator Sheath550-013550-0132015-02-06
00813132020941SightRail Manual Dilator Sheath555-508555-5082015-02-06
00813132020958SightRail Manual Dilator Sheath555-510555-5102015-02-06
00813132020965SightRail Manual Dilator Sheath555-511555-5112015-02-06
00813132020972SightRail Manual Dilator Sheath555-513555-5132015-02-06
00813132020002ELCA™110-001AA110-0012015-02-06
00813132020019ELCA™110-002AA110-0022015-02-06
00813132020026ELCA™110-003AA110-0032015-02-06
00813132020064ELCA™117-205AA117-2052015-02-06
00813132020071ELCA™120-008AA120-0082015-02-06
00813132025410ELCA™120-008AB120-0082017-12-04
00813132025427ELCA™117-205AB117-2052017-12-04
00813132025465ELCA™110-003AB110-0032017-12-04
00813132025472ELCA Coronary Laser Atherectomy Catheter110-002110-0022017-12-04

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