FDA.reportPublic FDA data

AngioSculpt®

Primary DI
M37022163510018
Brand
AngioSculpt®
Company
Spectranetics Corporation
Model
2216-35100-A
Catalog number
2216-35100
Device description
AngioSculpt® PTA Scoring Balloon Catheter
Published
2016-09-23
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
PNOCatheter, Percutaneous, Cutting/Scoring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNOCatheter, Percutaneous, Cutting/ScoringCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M37022163510018PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral angioplasty balloon catheter, basicA sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length100Millimeter
Outer Diameter3.5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

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

Regulatory Flags#

DUNS number
151047370
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

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Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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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
06923533801057Peripheral Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2026-05-15
B090XC2201450XO ConstrainZIEN MEDICAL TECHNOLOGIES, INC.PNO2026-02-03
B090XC2201451XO ConstrainZIEN MEDICAL TECHNOLOGIES, INC.PNO2026-02-03
06972253606060PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606084PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
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06972253606145PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606183PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
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06972253606329PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606343PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
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06972253606404PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606428PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606442PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606466PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606480PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253605780PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24
06972253605797PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24
06972253605803PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24
06972253605810PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24
06972253605827PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24
06972253605834PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24
06972253605841PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24
06972253605858PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24
06972253605865PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24
06972253605872PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-24