FDA.reportPublic FDA data

Cardiac valvuloplasty catheter

Definition
A sterile flexible tube with an inflatable balloon designed to perform plastic or restorative surgery on a cardiac valve, i.e., for the dilatation of atrioventricular, aortic, and pulmonary trunk valves. It is typically used for the percutaneous dilatation of commissural fusion in stenotic mitral valves and for annular, cuspal, and calcific nodular fractures, to improve cuspal mobility in adult calcific aortic stenosis, and for leaflet tearing in pulmonic valve stenosis. It may also be used for percutaneous balloon pericardiotomy. This is a single-use device.
GUDID devices
831
Last updated
2026-07-17 22:01:34

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
G825CVPSI19251KardiaPSIIntervention Tech, Inc. dba CorventionCVPSI19252026-06-24
G825CVPSI20251KardiaPSIIntervention Tech, Inc. dba CorventionCVPSI20252026-06-24
G825CVPSI21251KardiaPSIIntervention Tech, Inc. dba CorventionCVPSI21252026-06-24
G825CVPSI22251KardiaPSIIntervention Tech, Inc. dba CorventionCVPSI22252026-06-24
G825CVPSI23251KardiaPSIIntervention Tech, Inc. dba CorventionCVPSI23252026-06-24
G825CVPSI24251KardiaPSIIntervention Tech, Inc. dba CorventionCVPSI24252026-06-24
G825CVPSI25251KardiaPSIIntervention Tech, Inc. dba CorventionCVPSI25252026-06-24
G825CVPSI26251KardiaPSIIntervention Tech, Inc. dba CorventionCVPSI26252026-06-24
G825CVPSI27251KardiaPSIIntervention Tech, Inc. dba CorventionCVPSI27252026-06-24
G825CVPSI28251KardiaPSIIntervention Tech, Inc. dba CorventionCVPSI28252026-06-24
G825CVPSI29251KardiaPSIIntervention Tech, Inc. dba CorventionCVPSI29252026-06-24
06009698453789OutFlo Aortic Valve Valvuloplasty Dilatation Balloon CatheterDISA MEDINOTEC (PTY) LTDOTF1-180402026-05-20
06009698453796OutFlo Aortic Valve Valvuloplasty Dilatation Balloon CatheterDISA MEDINOTEC (PTY) LTDOTF1-200402026-05-20
06009698453802OutFlo Aortic Valve Valvuloplasty Dilatation Balloon CatheterDISA MEDINOTEC (PTY) LTDOTF1-230402026-05-20
06009698453819OutFlo Aortic Valve Valvuloplasty Dilatation Balloon CatheterDISA MEDINOTEC (PTY) LTDOTF1-250402026-05-20
06009698453826OutFlo Aortic Valve Valvuloplasty Dilatation Balloon CatheterDISA MEDINOTEC (PTY) LTDOTF1-280402026-05-20
07290020101242ShortCutPI-CARDIA LTDZ-A-20.003-US2024-12-05
06934184005060ValvuloPro®Dongguan TT Medical, Inc.VBC15402024-05-10
06934184005077ValvuloPro®Dongguan TT Medical, Inc.VBC18402024-05-10
06934184005084ValvuloPro®Dongguan TT Medical, Inc.VBC21402024-05-10
06934184005091ValvuloPro®Dongguan TT Medical, Inc.VBC23402024-05-10
06934184005107ValvuloPro®Dongguan TT Medical, Inc.VBC26402024-05-10
06934184005114ValvuloPro®Dongguan TT Medical, Inc.VBC29402024-05-10
14960685201228INOUE BALLOON ATORAY INDUSTRIES,INC.PTAV-20R2023-06-01
14960685201235INOUE BALLOON ATORAY INDUSTRIES,INC.PTAV-22R2023-06-01
14960685201242INOUE BALLOON ATORAY INDUSTRIES,INC.PTAV-24R2023-06-01
14960685201259INOUE BALLOON ATORAY INDUSTRIES,INC.PTAV-26R2023-06-01
14960685201341INOUE BALLOON ATORAY INDUSTRIES,INC.PTAV-16R2023-06-01
14960685201358INOUE BALLOON ATORAY INDUSTRIES,INC.PTAV-18R2023-06-01
14960685201389INOUE BALLOON ATORAY INDUSTRIES,INC.PTAV-16RP2023-06-01
14960685201396INOUE BALLOON ATORAY INDUSTRIES,INC.PTAV-18RP2023-06-01
14960685201402INOUE BALLOON ATORAY INDUSTRIES,INC.PTAV-20RP2023-06-01
14960685201419INOUE BALLOON ATORAY INDUSTRIES,INC.PTAV-22RP2023-06-01
14960685201426INOUE BALLOON ATORAY INDUSTRIES,INC.PTAV-24RP2023-06-01
14960685201433INOUE BALLOON ATORAY INDUSTRIES,INC.PTAV-26RP2023-06-01
04046964326837Z-MED™B BRAUN INTERVENTIONAL SYSTEMS, INC6102342016-08-09
04046964326851Z-MED™B BRAUN INTERVENTIONAL SYSTEMS, INC6102372016-08-09
04046964326899Z-MED™B BRAUN INTERVENTIONAL SYSTEMS, INC6102422016-08-09
04046964328480Z-MED™B BRAUN INTERVENTIONAL SYSTEMS, INC6104422016-08-09
04046964328503Z-MED™B BRAUN INTERVENTIONAL SYSTEMS, INC6104442016-08-09
04046964328541Z-MED™B BRAUN INTERVENTIONAL SYSTEMS, INC6104462016-08-09
04046964328749Z-MED™B BRAUN INTERVENTIONAL SYSTEMS, INC6104562016-08-09
04046964328787Z-MED™B BRAUN INTERVENTIONAL SYSTEMS, INC6104582016-08-09
04046964328800Z-MED™B BRAUN INTERVENTIONAL SYSTEMS, INC6104592016-08-09
04046964328824Z-MED™B BRAUN INTERVENTIONAL SYSTEMS, INC6104602016-08-09
04046964328961Z-MED™B BRAUN INTERVENTIONAL SYSTEMS, INC6104672016-08-09
04046964328978Z-MED™B BRAUN INTERVENTIONAL SYSTEMS, INC6104682016-08-09
04046964328992Z-MED™B BRAUN INTERVENTIONAL SYSTEMS, INC6104692016-08-09
04046964329012Z-MED™B BRAUN INTERVENTIONAL SYSTEMS, INC6104702016-08-09
04046964329036Z-MED™B BRAUN INTERVENTIONAL SYSTEMS, INC6104722016-08-09
04046964329098Z-MED™B BRAUN INTERVENTIONAL SYSTEMS, INC6104752016-08-09
04046964329111Z-MED™B BRAUN INTERVENTIONAL SYSTEMS, INC6104762016-08-09
04046964329135Z-MED™B BRAUN INTERVENTIONAL SYSTEMS, INC6104772016-08-09
04046964329159Z-MED™B BRAUN INTERVENTIONAL SYSTEMS, INC6104782016-08-09
04046964329173Z-MED™B BRAUN INTERVENTIONAL SYSTEMS, INC6104792016-08-09
04046964329197Z-MED™B BRAUN INTERVENTIONAL SYSTEMS, INC6104802016-08-09
04046964329210Z-MED™B BRAUN INTERVENTIONAL SYSTEMS, INC6104812016-08-09
04046964329234Z-MED™B BRAUN INTERVENTIONAL SYSTEMS, INC6104822016-08-09
04046964329258Z-MED™B BRAUN INTERVENTIONAL SYSTEMS, INC6104832016-08-09
04046964329272Z-MED™B BRAUN INTERVENTIONAL SYSTEMS, INC6104842016-08-09
04046964329296Z-MED™B BRAUN INTERVENTIONAL SYSTEMS, INC6104852016-08-09
04046964329319Z-MED™B BRAUN INTERVENTIONAL SYSTEMS, INC6104862016-08-09
04046964329333Z-MED™B BRAUN INTERVENTIONAL SYSTEMS, INC6104872016-08-09
04046964329357Z-MED™B BRAUN INTERVENTIONAL SYSTEMS, INC6104882016-08-09
04046964329371Z-MED™B BRAUN INTERVENTIONAL SYSTEMS, INC6104892016-08-09
04046964329395Z-MED™B BRAUN INTERVENTIONAL SYSTEMS, INC6104912016-08-09
04046964329418Z-MED™B BRAUN INTERVENTIONAL SYSTEMS, INC6104922016-08-09
04046964329524TYSHAK®B BRAUN INTERVENTIONAL SYSTEMS, INC6105002016-08-09
04046964329548TYSHAK®B BRAUN INTERVENTIONAL SYSTEMS, INC6105012016-08-09
04046964329623TYSHAK®B BRAUN INTERVENTIONAL SYSTEMS, INC6105052016-08-09
04046964329661TYSHAK®B BRAUN INTERVENTIONAL SYSTEMS, INC6105072016-08-09
04046964329685TYSHAK®B BRAUN INTERVENTIONAL SYSTEMS, INC6105082016-08-09
04046964329708TYSHAK®B BRAUN INTERVENTIONAL SYSTEMS, INC6105092016-08-09
04046964329722TYSHAK®B BRAUN INTERVENTIONAL SYSTEMS, INC6105102016-08-09
04046964329791TYSHAK®B BRAUN INTERVENTIONAL SYSTEMS, INC6105132016-08-09
04046964329852TYSHAK®B BRAUN INTERVENTIONAL SYSTEMS, INC6105162016-08-09
04046964329937TYSHAK®B BRAUN INTERVENTIONAL SYSTEMS, INC6105202016-08-09
04046964329951TYSHAK®B BRAUN INTERVENTIONAL SYSTEMS, INC6105212016-08-09
04046964329975TYSHAK®B BRAUN INTERVENTIONAL SYSTEMS, INC6105222016-08-09
04046964329999TYSHAK®B BRAUN INTERVENTIONAL SYSTEMS, INC6105232016-08-09