FDA.reportPublic FDA data

AngioSculpt OTW PTA Scoring Balloon Catheter

Primary DI
00813132021276
Brand
AngioSculpt OTW PTA Scoring Balloon Catheter
Company
The Spectranetics Corporation
Model
2039-2520
Catalog number
2039-2520
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
00813132021276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813132021276008131320212768131320212760813132021276

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
Balloon Diameter2.5Millimeter
Balloon Length20Millimeter
Length20Millimeter
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
1-800-633-0960complaints@spnc.com
1-800-633-0960SPNC-complaints@philips.com
(800) 228-4728IGTD.CustomerInquiry@philips.com

Regulatory Flags#

DUNS number
080949732
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813132021283AngioSculpt OTW PTA Scoring Balloon Catheter2039-30202039-30202016-09-23
00813132021290AngioSculpt OTW PTA Scoring Balloon Catheter2039-35202039-35202016-09-23
00813132021306AngioSculpt OTW PTA Scoring Balloon Catheter2155-20402155-20402016-09-23
00813132021313AngioSculpt OTW PTA Scoring Balloon Catheter2155-25402155-25402016-09-23
00813132021320AngioSculpt OTW PTA Scoring Balloon Catheter2155-30402155-30402016-09-23
00813132021337AngioSculpt OTW PTA Scoring Balloon Catheter2155-35402155-35402016-09-23
00813132021344AngioSculpt OTW PTA Scoring Balloon Catheter2076-40202076-40202016-09-23
00813132021351AngioSculpt OTW PTA Scoring Balloon Catheter2076-40402076-40402016-09-23
00813132021368AngioSculpt OTW PTA Scoring Balloon Catheter2076-50202076-50202016-09-23
00813132021375AngioSculpt OTW PTA Scoring Balloon Catheter2076-50402076-50402016-09-23
00813132021382AngioSculpt OTW PTA Scoring Balloon Catheter2076-60202076-60202016-09-23
00813132021399AngioSculpt OTW PTA Scoring Balloon Catheter2076-60402076-60402016-09-23
00813132021405AngioSculpt OTW PTA Scoring Balloon Catheter2092-40402092-40402016-09-23
00813132021412AngioSculpt OTW PTA Scoring Balloon Catheter2092-50402092-50402016-09-23
00813132021429AngioSculpt OTW PTA Scoring Balloon Catheter2092-60202092-60202016-09-23
00813132021436AngioSculpt OTW PTA Scoring Balloon Catheter2092-60402092-60402016-09-23
00813132021443AngioSculpt OTW PTA Scoring Balloon Catheter2105-60202105-60202016-09-23
00813132021450AngioSculpt OTW PTA Scoring Balloon Catheter2105-60402105-60402016-09-23
00813132021559AngioSculpt OTW PTA Scoring Balloon Catheter with HydroCross Coating2249-402002249-402002016-09-23
00813132021566AngioSculpt OTW PTA Scoring Balloon Catheter with HydroCross Coating2249-502002249-502002016-09-23

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
06972253606107PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606121PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606145PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606183PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606206PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606220PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606268PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606329PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606343PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
06972253606367PTA Scoring Balloon Dilatation CatheterDK Medical Technology Co., Ltd.PNO2025-07-30
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