AngioSculpt®PTCA Scoring Balloon Catheter

GUDID 00813132022044

Spectranetics Corporation

Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring Coronary angioplasty balloon catheter, cutting/scoring
Primary Device ID00813132022044
NIH Device Record Keye6820e59-bc65-4ffa-bc0d-5ab9f2b9c3ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameAngioSculpt®PTCA Scoring Balloon Catheter
Version Model Number2200-2520
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
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com
Phone1-800-633-0960
EmailSPNC-complaints@philips.com

Device Dimensions

Outer Diameter2.5 Millimeter
Balloon Length20 Millimeter
Outer Diameter2.5 Millimeter
Balloon Length20 Millimeter
Outer Diameter2.5 Millimeter
Balloon Length20 Millimeter
Outer Diameter2.5 Millimeter
Balloon Length20 Millimeter
Outer Diameter2.5 Millimeter
Balloon Length20 Millimeter
Outer Diameter2.5 Millimeter
Balloon Length20 Millimeter
Outer Diameter2.5 Millimeter
Balloon Length20 Millimeter
Outer Diameter2.5 Millimeter
Balloon Length20 Millimeter
Outer Diameter2.5 Millimeter
Balloon Length20 Millimeter
Outer Diameter2.5 Millimeter
Balloon Length20 Millimeter
Outer Diameter2.5 Millimeter
Balloon Length20 Millimeter
Outer Diameter2.5 Millimeter
Balloon Length20 Millimeter
Outer Diameter2.5 Millimeter
Balloon Length20 Millimeter
Outer Diameter2.5 Millimeter
Balloon Length20 Millimeter
Outer Diameter2.5 Millimeter
Balloon Length20 Millimeter
Outer Diameter2.5 Millimeter
Balloon Length20 Millimeter
Outer Diameter2.5 Millimeter
Balloon Length20 Millimeter
Outer Diameter2.5 Millimeter
Balloon Length20 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Length20 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Length20 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Length20 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Length20 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Length20 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Length20 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Length20 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Length20 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Length20 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Length20 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Length20 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Length20 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Length20 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Length20 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Length20 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Length20 Millimeter
Balloon Diameter2.5 Millimeter
Balloon Length20 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100813132022044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NWXCatheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00813132022044]

Ethylene Oxide


[00813132022044]

Ethylene Oxide


[00813132022044]

Ethylene Oxide


[00813132022044]

Ethylene Oxide


[00813132022044]

Ethylene Oxide


[00813132022044]

Ethylene Oxide


[00813132022044]

Ethylene Oxide


[00813132022044]

Ethylene Oxide


[00813132022044]

Ethylene Oxide


[00813132022044]

Ethylene Oxide


[00813132022044]

Ethylene Oxide


[00813132022044]

Ethylene Oxide


[00813132022044]

Ethylene Oxide


[00813132022044]

Ethylene Oxide


[00813132022044]

Ethylene Oxide


[00813132022044]

Ethylene Oxide


[00813132022044]

Ethylene Oxide


[00813132022044]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-10-07
Device Publish Date2015-03-09

On-Brand Devices [AngioSculpt®PTCA Scoring Balloon Catheter]

00813132022181AngioSculpt® PTCA Scoring Balloon Catheter
00813132022174AngioSculpt® PTCA Scoring Balloon Catheter
00813132022167AngioSculpt® PTCA Scoring Balloon Catheter
00813132022150AngioSculpt® PTCA Scoring Balloon Catheter
00813132022143AngioSculpt® PTCA Scoring Balloon Catheter
00813132022136AngioSculpt® PTCA Scoring Balloon Catheter
00813132022129AngioSculpt® PTCA Scoring Balloon Catheter
00813132022112AngioSculpt® PTCA Scoring Balloon Catheter
00813132022105AngioSculpt® PTCA Scoring Balloon Catheter
00813132022099AngioSculpt® PTCA Scoring Balloon Catheter
00813132022082AngioSculpt® PTCA Scoring Balloon Catheter
00813132022075AngioSculpt® PTCA Scoring Balloon Catheter
008131320220682200-3520
008131320220512200-3020
008131320220442200-2520
008131320220372200-2020
00813132021245AngioSculpt® PTCA Scoring Balloon Catheter
00813132021238AngioSculpt® PTCA Scoring Balloon Catheter
00813132021221AngioSculpt® PTCA Scoring Balloon Catheter
00813132021214AngioSculpt® PTCA Scoring Balloon Catheter
00813132021207AngioSculpt® PTCA Scoring Balloon Catheter
00813132021191AngioSculpt® PTCA Scoring Balloon Catheter
00813132021184AngioSculpt® PTCA Scoring Balloon Catheter
00813132021177AngioSculpt® PTCA Scoring Balloon Catheter
00813132021160AngioSculpt® PTCA Scoring Balloon Catheter
00813132021153AngioSculpt® PTCA Scoring Balloon Catheter
00813132021146AngioSculpt® PTCA Scoring Balloon Catheter
00813132021139AngioSculpt® PTCA Scoring Balloon Catheter
00813132021122AngioSculpt® PTCA Scoring Balloon Catheter
00813132021115AngioSculpt® PTCA Scoring Balloon Catheter
00813132021108AngioSculpt® PTCA Scoring Balloon Catheter
00813132021092AngioSculpt® PTCA Scoring Balloon Catheter
00813132021085AngioSculpt® PTCA Scoring Balloon Catheter
00813132021078AngioSculpt® PTCA Scoring Balloon Catheter
00813132021061AngioSculpt® PTCA Scoring Balloon Catheter
00813132021054AngioSculpt® PTCA Scoring Balloon Catheter
00813132021047AngioSculpt® PTCA Scoring Balloon Catheter
00813132021030AngioSculpt® PTCA Scoring Balloon Catheter
00813132021023AngioSculpt® PTCA Scoring Balloon Catheter
00813132021016AngioSculpt® PTCA 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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