Home GUDID M917OTW7017BA0 FLASH Ostial System OTW
Primary DI M917OTW7017BA0
Brand FLASH Ostial System OTW
Company Verge Medical, Inc.
Model OTW7017BA
Catalog number OTW7017BA
Device description "FLASH Ostial System, Dual Balloon Angioplasty Catheter, 0.035"" OVER-THE-WIRE, 7.0mm x 17mm"
Published 2016-09-22
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name LIT Catheter, Angioplasty, Peripheral, Transluminal
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M917OTW7017BA0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Peripheral angioplasty balloon catheter, basic A 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 Type Value Unit Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store in a dry location at room temperature (~23°C)
Regulatory Flags# DUNS number 078708447 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00810219610071 FLASH Flex Aorto-Ostial Angioplasty System FF30A FF30A 2026-05-22 00810219610088 FLASH Flex Aorto-Ostial Angioplasty System FF35A FF35A 2026-05-22 00810219610095 FLASH Flex Aorto-Ostial Angioplasty System FF40A FF40A 2026-05-22 00810219610101 FLASH Flex Aorto-Ostial Angioplasty System FF45A FF45A 2026-05-22 00810219610118 FLASH Flex Aorto-Ostial Angioplasty System FF50A FF50A 2026-05-22 M917RVHD0 RoVo Mechanical Thrombectomy System RVHD RVHD 2026-02-06 M917RVHD1 RoVo Mechanical Thrombectomy System RVHD RVHD 2026-02-06 M917VRG7513B30 RoVo Mechanical Thrombectomy System VRG7513B3 VRG7513B3 2026-02-06 M917OAB6019BA0 FLASH Ostial System OAB6019BA OAB6019BA 2016-09-22 M917OAB7019BA0 FLASH Ostial System OAB7019BA OAB7019BA 2016-09-22 M917OCB4014BA0 FLASH Ostial System OCB4014BA OCB4014BA 2016-09-22 M917OCB4514BA0 FLASH Ostial System OCB4514BA OCB4514BA 2016-09-22 M917OCB5019BA0 FLASH Ostial System OCB5019BA OCB5019BA 2016-09-22 M917OAB6014BA0 FLASH Ostial System OAB6014BA OAB6014BA 2016-09-22 M917OTW6012BA0 FLASH Ostial System OTW OTW6012BA OTW6012BA 2016-09-22 M917OTW7012BA0 FLASH Ostial System OTW OTW7012BA OTW7012BA 2016-09-22 M917OCB3008BA0 FLASH MINI Ostial System OCB3008BA OCB3008BA 2016-09-22 M917OCB3508BA0 FLASH MINI Ostial System OCB3508BA OCB3508BA 2016-09-22 M917OCB4008BA0 FLASH MINI Ostial System OCB4008BA OCB4008BA 2016-09-22 M917OCB4508BA0 FLASH MINI Ostial System OCB4508BA OCB4508BA 2016-09-22
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 08033477048772 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048802 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048833 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048864 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048888 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048925 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048956 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048987 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049014 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049045 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049069 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049076 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049106 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049137 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049168 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049199 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049212 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049229 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049250 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049281 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049311 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049373 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049434 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049397 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049090 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048727 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048734 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048765 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048796 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048819 REEF HP MEDTRONIC, INC. LIT 2016-06-19
ostialcorp.com