FDA.reportPublic FDA data

Coronary angioplasty balloon catheter, basic

Definition
A flexible tube designed for percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible balloon(s) at its distal tip. It is typically available as: 1) an over-the-wire (OTW) type that has a double or triple-lumen, one for the guidewire and one or two for single- or double-balloon inflation; and 2) a rapid exchange (RX) type with a single-lumen. It is available in various sizes for the dilatation of small, narrowed, or obstructed coronary arteries or bypass grafts. It may also be intended for pre- or post-dilatation of a balloon-expandable stent (not included) in the coronary arteries. This is a single-use device.
GUDID devices
3,691
Last updated
2026-09-04 23:10:36

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00643169559820Euphora™MEDTRONIC, INC.EUP1510X2016-04-25
00643169559837Euphora™MEDTRONIC, INC.EUP1512X2016-04-11
00643169559844Euphora™MEDTRONIC, INC.EUP1515X2016-04-11
00643169559851Euphora™MEDTRONIC, INC.EUP1520X2016-04-11
00643169559868Euphora™MEDTRONIC, INC.EUP2006X2016-04-11
00643169559875Euphora™MEDTRONIC, INC.EUP2010X2016-04-11
00643169559905Euphora™MEDTRONIC, INC.EUP2020X2016-04-11
00643169559912Euphora™MEDTRONIC, INC.EUP2025X2016-04-25
00643169559929Euphora™MEDTRONIC, INC.EUP2030X2016-04-11
00643169559936Euphora™MEDTRONIC, INC.EUP22506X2016-04-11
00643169559943Euphora™MEDTRONIC, INC.EUP22510X2016-04-11
00643169559950Euphora™MEDTRONIC, INC.EUP22512X2016-04-11
00643169559967Euphora™MEDTRONIC, INC.EUP22515X2016-04-11
00643169559974Euphora™MEDTRONIC, INC.EUP22520X2016-04-11
00643169559981Euphora™MEDTRONIC, INC.EUP22525X2016-04-11
00643169559998Euphora™MEDTRONIC, INC.EUP2506X2016-04-11
00643169560000Euphora™MEDTRONIC, INC.EUP2510X2016-04-11
00643169560017Euphora™MEDTRONIC, INC.EUP2512X2016-04-11
00643169560024Euphora™MEDTRONIC, INC.EUP2515X2016-04-11
00643169560031Euphora™MEDTRONIC, INC.EUP2520X2016-04-11
00643169560048Euphora™MEDTRONIC, INC.EUP2525X2016-04-11
00643169560055Euphora™MEDTRONIC, INC.EUP2530X2016-04-11
00643169560062Euphora™MEDTRONIC, INC.EUP27506X2016-04-11
00643169560079Euphora™MEDTRONIC, INC.EUP27510X2016-04-11
00643169560086Euphora™MEDTRONIC, INC.EUP27512X2016-04-11
00643169560093Euphora™MEDTRONIC, INC.EUP27515X2016-04-11
00643169560109Euphora™MEDTRONIC, INC.EUP27520X2016-04-11
00643169560116Euphora™MEDTRONIC, INC.EUP27525X2016-04-11
00643169560123Euphora™MEDTRONIC, INC.EUP3006X2016-04-11
00643169560130Euphora™MEDTRONIC, INC.EUP3010X2016-04-11
00643169560147Euphora™MEDTRONIC, INC.EUP3012X2016-04-11
00643169560154Euphora™MEDTRONIC, INC.EUP3015X2016-04-11
00643169560161Euphora™MEDTRONIC, INC.EUP3020X2016-04-11
00643169560178Euphora™MEDTRONIC, INC.EUP3025X2016-04-11
00643169560185Euphora™MEDTRONIC, INC.EUP3030X2016-04-11
00643169560192Euphora™MEDTRONIC, INC.EUP32506X2016-04-11
00643169560208Euphora™MEDTRONIC, INC.EUP32510X2016-04-11
00643169560215Euphora™MEDTRONIC, INC.EUP32512X2016-04-11
00643169560222Euphora™MEDTRONIC, INC.EUP32515X2016-04-11
00643169560253Euphora™MEDTRONIC, INC.EUP3506X2016-04-11
00643169560260Euphora™MEDTRONIC, INC.EUP3510X2016-04-11
00643169560277Euphora™MEDTRONIC, INC.EUP3512X2016-04-11
00643169560291Euphora™MEDTRONIC, INC.EUP3520X2016-04-11
00643169560307Euphora™MEDTRONIC, INC.EUP3525X2016-04-11
00643169560321Euphora™MEDTRONIC, INC.EUP37506X2016-04-11
00643169560338Euphora™MEDTRONIC, INC.EUP37510X2016-04-11
00643169560345Euphora™MEDTRONIC, INC.EUP37512X2016-04-11
00643169560383Euphora™MEDTRONIC, INC.EUP4006X2016-04-11
00643169560390Euphora™MEDTRONIC, INC.EUP4010X2016-04-11
00643169560406Euphora™MEDTRONIC, INC.EUP4012X2016-04-11
00643169560413Euphora™MEDTRONIC, INC.EUP4015X2016-04-11
00643169560420Euphora™MEDTRONIC, INC.EUP4020X2016-04-11
00643169560444Euphora™MEDTRONIC, INC.EUP4030X2016-04-11
06971591769062Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.KCTO1500062026-04-19
06971591769079Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.KCTO1500082026-04-19
06971591769086Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.KCTO1500102026-04-19
06971591769093Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.KCTO1500122026-04-19
06971591769109Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.KCTO1500152026-04-19
06971591769116Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.KCTO1500182026-04-19
06971591769123Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.KCTO1500202026-04-19
06971591769130Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.KCTO1500252026-04-19
07640142570509OPN NCSIS Medical AG200-010-0042022-12-12
07640142570516OPN NCSIS Medical AG200-015-0042022-12-12
07640142570523OPN NCSIS Medical AG200-020-0042022-12-12
07640142570530OPN NCSIS Medical AG250-010-0042022-12-12
07640142570547OPN NCSIS Medical AG250-015-0042022-12-12
07640142570554OPN NCSIS Medical AG250-020-0042022-12-12
07640142570561OPN NCSIS Medical AG300-010-0042022-12-12
07640142570578OPN NCSIS Medical AG300-015-0042022-12-12
07640142570585OPN NCSIS Medical AG300-020-0042022-12-12
07640142570592OPN NCSIS Medical AG350-010-0042022-12-12
07640142570608OPN NCSIS Medical AG350-015-0042022-12-12
07640142570615OPN NCSIS Medical AG350-020-0042022-12-12
07640142570622OPN NCSIS Medical AG400-010-0042022-12-12
07640142570639OPN NCSIS Medical AG400-015-0042022-12-12
07640142570646OPN NCSIS Medical AG400-020-0042022-12-12
07640142572855OPN NCSIS Medical AG150-010-0042022-12-12
07640142572862OPN NCSIS Medical AG150-015-0042022-12-12
07640142572879OPN NCSIS Medical AG150-020-0042022-12-12
07640142572886OPN NCSIS Medical AG450-010-0042022-12-12