FDA.reportPublic FDA data

Peripheral angioplasty balloon catheter, basic

Definition
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 microsurgical blades (atherotomes) to score the plaque. This is a single-use device.
GUDID devices
4,462
Last updated
2019-06-26 05:22:25

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
06091403538669"Ebony 0.014"" PTA Rx Catheter"NATEC MEDICAL LTDPC045_00-20US2019-06-17
10705032047371POWERFLEXCordis US Corp.SRA01642016-08-01
14858218671006Test2 Release 1.6.3Booz Allen Hamilton Inc.Test2XML2017-05-05
14858218671008Test2 Release 1.6.3Booz Allen Hamilton Inc.Test2XML2017-05-05
14858218671009Test2 Release 1.6.3Booz Allen Hamilton Inc.Test2XML2017-05-05
20705032001516POWERFLEXCORDIS CORPORATION4150020S2016-08-01
20705032001523POWERFLEXCORDIS CORPORATION4150020T2016-08-01
20705032001547POWERFLEXCordis US Corp.4150040S2016-08-01
20705032001554POWERFLEXCordis US Corp.4150040T2016-08-01
20705032001561POWERFLEXCORDIS CORPORATION4150060S2016-08-01
20705032001585POWERFLEXCordis US Corp.4154020S2016-08-01
20705032001592POWERFLEXCordis US Corp.4154020T2016-08-01
20705032001615POWERFLEXCordis US Corp.4154040S2016-08-01
20705032001622POWERFLEXCordis US Corp.4154040T2016-08-01
20705032001639POWERFLEXCordis US Corp.4154060S2016-08-01
20705032001653POWERFLEXCordis US Corp.4155020S2016-08-01
20705032001660POWERFLEXCordis US Corp.4155020T2016-08-01
20705032001684POWERFLEXCORDIS CORPORATION4155040S2016-08-01
20705032001691POWERFLEXCORDIS CORPORATION4155040T2016-08-01
20705032001707POWERFLEXCordis US Corp.4155060S2016-08-01
20705032001721POWERFLEXCordis US Corp.4156020S2016-08-01
20705032001738POWERFLEXCordis US Corp.4156020T2016-08-01
20705032001752POWERFLEXCordis US Corp.4156040S2016-08-01
20705032001769POWERFLEXCordis US Corp.4156040T2016-08-01
20705032001776POWERFLEXCORDIS CORPORATION4156060S2016-08-01
20705032001783POWERFLEXCordis US Corp.4156060T2016-08-01
20705032001806POWERFLEXCordis US Corp.4157020S2016-08-01
20705032001813POWERFLEXCordis US Corp.4157020T2016-08-01
20705032001837POWERFLEXCORDIS CORPORATION4157040S2016-08-01
20705032001844POWERFLEXCORDIS CORPORATION4157040T2016-08-01
20705032001851POWERFLEXCordis US Corp.4157060S2016-08-01
20705032001868POWERFLEXCORDIS CORPORATION4157060T2016-08-01
20705032001882POWERFLEXCordis US Corp.4158020S2016-08-01
20705032001899POWERFLEXCORDIS CORPORATION4158020T2016-08-01
20705032001912POWERFLEXCORDIS CORPORATION4158030S2016-08-01
20705032001929POWERFLEXCORDIS CORPORATION4158030T2016-08-01
20705032001943POWERFLEXCordis US Corp.4158040S2016-08-01
20705032001950POWERFLEXCordis US Corp.4158040T2016-08-01
20705032001974POWERFLEXCORDIS CORPORATION4158060S2016-08-01
20705032001981POWERFLEXCordis US Corp.4158060T2016-08-01
20705032002001POWERFLEXCORDIS CORPORATION4159020S2016-08-01
20705032002018POWERFLEXCORDIS CORPORATION4159020T2016-08-01
20705032002032POWERFLEXCORDIS CORPORATION4159040S2016-08-01
20705032002049POWERFLEXCORDIS CORPORATION4159040T2016-08-01
20705032002063MAXI LDCordis US Corp.4161440L2016-08-01
20705032002070MAXI LDCordis US Corp.4161440S2016-08-01
20705032002087MAXI LDCordis US Corp.4161460L2016-08-01
20705032002094MAXI LDCORDIS CORPORATION4161460S2016-08-01
20705032002100MAXI LDCORDIS CORPORATION4161520LF2016-08-01
20705032002117MAXI LDCORDIS CORPORATION4161520SF2016-08-01
20705032002131MAXI LDCordis US Corp.4161540L2016-08-01
20705032002148MAXI LDCordis US Corp.4161540S2016-08-01
20705032002162MAXI LDCordis US Corp.4161560L2016-08-01
20705032002179MAXI LDCordis US Corp.4161560S2016-08-01
20705032002193MAXI LDCordis US Corp.4161640L2016-08-01
20705032002209MAXI LDCordis US Corp.4161640S2016-08-01
20705032002216MAXI LDCordis US Corp.4161660L2016-08-01
20705032002223MAXI LDCORDIS CORPORATION4161660S2016-08-01
20705032002230MAXI LDCordis US Corp.4161840L2016-08-01
20705032002247MAXI LDCordis US Corp.4161840S2016-08-01
20705032002254MAXICordis US Corp.4161860L2016-08-01
20705032002261MAXI LDCordis US Corp.4161860S2016-08-01
20705032002278MAXI LDCordis US Corp.4162040L2016-08-01
20705032002285MAXI LDCordis US Corp.4162040S2016-08-01
20705032002308MAXI LDCordis US Corp.4162060L2016-08-01
20705032002315MAXI LDCordis US Corp.4162060S2016-08-01
20705032002339MAXI LDCordis US Corp.4162080LF2016-08-01
20705032002346MAXI LDCORDIS CORPORATION4162080SF2016-08-01
20705032002377MAXI LDCORDIS CORPORATION4162240L2016-08-01
20705032002384MAXI LDCordis US Corp.4162240S2016-08-01
20705032002391MAXI LDCordis US Corp.4162540L2016-08-01
20705032002407MAXI LDCordis US Corp.4162540S2016-08-01
20705032002421MAXI LDCordis US Corp.4171440L2016-08-01
20705032002438MAXI LDCordis US Corp.4171440S2016-08-01
20705032002445MAXI LDCordis US Corp.4171460L2016-08-01
20705032002452MAXI LDCordis US Corp.4171460S2016-08-01
20705032002469MAXI LDCORDIS CORPORATION4171520L2016-08-01
20705032002476MAXI LDCORDIS CORPORATION4171520S2016-08-01
20705032002490MAXI LDCordis US Corp.4171540L2016-08-01
20705032002506MAXI LDCORDIS CORPORATION4171540S2016-08-01