AngioSculpt® 2237-40100

GUDID M37022374010017

AngioSculpt® PTA Scoring Balloon Catheter

Spectranetics Corporation

Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic
Primary Device IDM37022374010017
NIH Device Record Key000a0217-1fbe-459a-a214-69db9c5f8581
Commercial Distribution Discontinuation2020-02-20
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAngioSculpt®
Version Model Number2237-40100-A
Catalog Number2237-40100
Company DUNS151047370
Company NameSpectranetics Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com
Phone1-800-633-0960
Emailcomplaints@spnc.com

Device Dimensions

Outer Diameter4 Millimeter
Length100 Millimeter
Outer Diameter4 Millimeter
Length100 Millimeter
Outer Diameter4 Millimeter
Length100 Millimeter
Outer Diameter4 Millimeter
Length100 Millimeter
Outer Diameter4 Millimeter
Length100 Millimeter
Outer Diameter4 Millimeter
Length100 Millimeter
Outer Diameter4 Millimeter
Length100 Millimeter
Outer Diameter4 Millimeter
Length100 Millimeter
Outer Diameter4 Millimeter
Length100 Millimeter
Outer Diameter4 Millimeter
Length100 Millimeter
Outer Diameter4 Millimeter
Length100 Millimeter
Outer Diameter4 Millimeter
Length100 Millimeter
Outer Diameter4 Millimeter
Length100 Millimeter
Outer Diameter4 Millimeter
Length100 Millimeter
Outer Diameter4 Millimeter
Length100 Millimeter
Outer Diameter4 Millimeter
Length100 Millimeter
Outer Diameter4 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM37022374010017 [Primary]

FDA Product Code

PNOCatheter, Percutaneous, Cutting/Scoring

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[M37022374010017]

Ethylene Oxide


[M37022374010017]

Ethylene Oxide


[M37022374010017]

Ethylene Oxide


[M37022374010017]

Ethylene Oxide


[M37022374010017]

Ethylene Oxide


[M37022374010017]

Ethylene Oxide


[M37022374010017]

Ethylene Oxide


[M37022374010017]

Ethylene Oxide


[M37022374010017]

Ethylene Oxide


[M37022374010017]

Ethylene Oxide


[M37022374010017]

Ethylene Oxide


[M37022374010017]

Ethylene Oxide


[M37022374010017]

Ethylene Oxide


[M37022374010017]

Ethylene Oxide


[M37022374010017]

Ethylene Oxide


[M37022374010017]

Ethylene Oxide


[M37022374010017]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-21
Device Publish Date2016-09-23

On-Brand Devices [AngioSculpt®]

00813132022952AngioSculpt® PTA Scoring Balloon Catheter with HydroCross Coating
00813132022945AngioSculpt® PTA Scoring Balloon Catheter with HydroCross Coating
00813132022938AngioSculpt® PTA Scoring Balloon Catheter with HydroCross Coating
00813132022921AngioSculpt® PTA Scoring Balloon Catheter with HydroCross Coating
00813132022914AngioSculpt® PTA Scoring Balloon Catheter with HydroCross Coating
00813132022907AngioSculpt® PTA Scoring Balloon Catheter with HydroCross Coating
00813132022891AngioSculpt® PTA Scoring Balloon Catheter with HydroCross Coating
00813132022846AngioSculpt® PTA Scoring Balloon Catheter with HydroCross Coating
00813132022839AngioSculpt® PTA Scoring Balloon Catheter with HydroCross Coating
00813132022822AngioSculpt® PTA Scoring Balloon Catheter with HydroCross Coating
00813132022242AngioSculpt® PTA Scoring Balloon Catheter
00813132022235AngioSculpt® PTA Scoring Balloon Catheter
00813132022228AngioSculpt® PTA Scoring Balloon Catheter
00813132022211AngioSculpt® PTA Scoring Balloon Catheter
00813132022204AngioSculpt® PTA Scoring Balloon Catheter
00813132022198AngioSculpt® PTA Scoring Balloon Catheter
00813132021955AngioSculpt® PTA Scoring Balloon Catheter
00813132021948AngioSculpt® PTA Scoring Balloon Catheter
00813132021931AngioSculpt® PTA Scoring Balloon Catheter
00813132021924AngioSculpt® PTA Scoring Balloon Catheter
00813132021887AngioSculpt® PTA Scoring Balloon Catheter
00813132021603AngioSculpt® PTA Scoring Balloon Catheter
00813132021597AngioSculpt® PTA Scoring Balloon Catheter
00813132021580AngioSculpt® PTA Scoring Balloon Catheter
00813132021573AngioSculpt® PTA Scoring Balloon Catheter with HydroCross Coating
00813132021566AngioSculpt® PTA Scoring Balloon Catheter with HydroCross Coating
00813132021559AngioSculpt® PTA Scoring Balloon Catheter with HydroCross Coating
00813132021542AngioSculpt® PTA Scoring Balloon Catheter
00813132021535AngioSculpt® PTA Scoring Balloon Catheter
00813132021528AngioSculpt® PTA Scoring Balloon Catheter
00813132021511AngioSculpt® PTA Scoring Balloon Catheter
00813132021504AngioSculpt® PTA Scoring Balloon Catheter
00813132021498AngioSculpt® PTA Scoring Balloon Catheter
00813132021450AngioSculpt® PTA Scoring Balloon Catheter
00813132021443AngioSculpt® PTA Scoring Balloon Catheter
00813132021436AngioSculpt® PTA Scoring Balloon Catheter
00813132021429AngioSculpt® PTA Scoring Balloon Catheter
00813132021412AngioSculpt® PTA Scoring Balloon Catheter
00813132021405AngioSculpt® PTA Scoring Balloon Catheter
00813132021399AngioSculpt® PTA Scoring Balloon Catheter
00813132021382AngioSculpt® PTA Scoring Balloon Catheter
00813132021375AngioSculpt® PTA Scoring Balloon Catheter
00813132021368AngioSculpt® PTA Scoring Balloon Catheter
00813132021351AngioSculpt® PTA Scoring Balloon Catheter
00813132021344AngioSculpt® PTA Scoring Balloon Catheter
00813132021337AngioSculpt® PTA Scoring Balloon Catheter
00813132021320AngioSculpt® PTA Scoring Balloon Catheter
00813132021313AngioSculpt® PTA Scoring Balloon Catheter
00813132021306AngioSculpt® PTA Scoring Balloon Catheter
00813132021290AngioSculpt® PTA Scoring Balloon Catheter

Trademark Results [AngioSculpt]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ANGIOSCULPT
ANGIOSCULPT
78263821 2920010 Live/Registered
AngioScore, Inc.
2003-06-18

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