AngioSculpt®Evo RX PTCA Scoring Balloon Catheter with hydrophilic coating 2200-3515-B

GUDID 00813132026936

AngioSculpt®Evo RX PTCA Scoring Balloon Catheter with hydrophilic coating

Spectranetics Corporation

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 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 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 ID00813132026936
NIH Device Record Keye5be3514-da35-48b9-af87-c7252a9d6cc0
Commercial Distribution StatusIn Commercial Distribution
Brand NameAngioSculpt®Evo RX PTCA Scoring Balloon Catheter with hydrophilic coating
Version Model Number2200-3515-B
Catalog Number2200-3515-B
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
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
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 Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Length15 Millimeter
Outer Diameter3.5 Millimeter
Balloon Length15 Millimeter
Outer Diameter3.5 Millimeter
Balloon Length15 Millimeter
Outer Diameter3.5 Millimeter
Balloon Length15 Millimeter
Outer Diameter3.5 Millimeter
Balloon Length15 Millimeter
Outer Diameter3.5 Millimeter
Balloon Length15 Millimeter
Outer Diameter3.5 Millimeter
Balloon Length15 Millimeter
Outer Diameter3.5 Millimeter
Balloon Length15 Millimeter
Outer Diameter3.5 Millimeter
Balloon Length15 Millimeter
Outer Diameter3.5 Millimeter
Balloon Length15 Millimeter
Outer Diameter3.5 Millimeter
Balloon Length15 Millimeter
Outer Diameter3.5 Millimeter
Balloon Length15 Millimeter
Outer Diameter3.5 Millimeter
Balloon Length15 Millimeter
Outer Diameter3.5 Millimeter
Balloon Length15 Millimeter
Outer Diameter3.5 Millimeter
Balloon Length15 Millimeter
Outer Diameter3.5 Millimeter
Balloon Length15 Millimeter
Outer Diameter3.5 Millimeter
Balloon Length15 Millimeter
Balloon Diameter3.5 Millimeter
Balloon Length15 Millimeter
Balloon Diameter3.5 Millimeter
Balloon Length15 Millimeter
Balloon Diameter3.5 Millimeter
Balloon Length15 Millimeter
Balloon Diameter3.5 Millimeter
Balloon Length15 Millimeter
Balloon Diameter3.5 Millimeter
Balloon Length15 Millimeter
Balloon Diameter3.5 Millimeter
Balloon Length15 Millimeter
Balloon Diameter3.5 Millimeter
Balloon Length15 Millimeter
Balloon Diameter3.5 Millimeter
Balloon Length15 Millimeter
Balloon Diameter3.5 Millimeter
Balloon Length15 Millimeter
Balloon Diameter3.5 Millimeter
Balloon Length15 Millimeter
Balloon Diameter3.5 Millimeter
Balloon Length15 Millimeter
Balloon Diameter3.5 Millimeter
Balloon Length15 Millimeter
Balloon Diameter3.5 Millimeter
Balloon Length15 Millimeter
Balloon Diameter3.5 Millimeter
Balloon Length15 Millimeter
Balloon Diameter3.5 Millimeter
Balloon Length15 Millimeter
Balloon Diameter3.5 Millimeter
Balloon Length15 Millimeter
Balloon Diameter3.5 Millimeter
Balloon Length15 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
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
GS100813132026936 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-07
Device Publish Date2020-09-29

On-Brand Devices [AngioSculpt®Evo RX PTCA Scoring Balloon Catheter with hydrophilic coating]

00813132026943AngioSculpt®Evo RX PTCA Scoring Balloon Catheter with hydrophilic coating
00813132026936AngioSculpt®Evo RX PTCA Scoring Balloon Catheter with hydrophilic coating
00813132026929AngioSculpt®Evo RX PTCA Scoring Balloon Catheter with hydrophilic coating
00813132026912AngioSculpt®Evo RX PTCA Scoring Balloon Catheter with hydrophilic coating
00813132026905AngioSculpt®Evo RX PTCA Scoring Balloon Catheter with hydrophilic coating
00813132026899AngioSculpt®Evo RX PTCA Scoring Balloon Catheter with hydrophilic coating
00813132026882AngioSculpt®Evo RX PTCA Scoring Balloon Catheter with hydrophilic coating
00813132026875AngioSculpt®Evo RX PTCA Scoring Balloon Catheter with hydrophilic coating
00813132026868AngioSculpt®Evo RX PTCA Scoring Balloon Catheter with hydrophilic coating
00813132026851AngioSculpt®Evo RX PTCA Scoring Balloon Catheter with hydrophilic coating
00813132026844AngioSculpt®Evo RX PTCA Scoring Balloon Catheter with hydrophilic coating
00813132026837AngioSculpt®Evo RX PTCA Scoring Balloon Catheter with hydrophilic coating
00813132026820AngioSculpt®Evo RX PTCA Scoring Balloon Catheter with hydrophilic coating
00813132026813AngioSculpt®Evo RX PTCA Scoring Balloon Catheter with hydrophilic coating
00813132026806AngioSculpt®Evo RX PTCA Scoring Balloon Catheter with hydrophilic coating
00813132026790AngioSculpt®Evo RX PTCA Scoring Balloon Catheter with hydrophilic coating

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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