FDA.reportPublic FDA data

AngioSculpt RX PTCA

Primary DI
00813132022037
Brand
AngioSculpt RX PTCA
Company
Spectranetics Corporation
Model
2200-2020
Catalog number
2200-2020
Device description
AngioSculpt RX PTCA Scoring Balloon Catheter, 2.0 mm x 20 mm
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P050018017

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P050018017ANGIOSCULPT SCORING BALLOON CATHETERSpectranetics Corp.2007-01-08NWX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813132022037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813132022037008131320220378131320220370813132022037

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Balloon Diameter2Millimeter
Balloon Length20Millimeter
Outer Diameter2Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry

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