FDA.reportPublic FDA data

KardiaPSI

Primary DI
G825CVPSI19251
Brand
KardiaPSI
Company
Intervention Tech, Inc. dba Corvention
Model
CVPSI1925
Catalog number
CVPSI1925
Device description
Balloon Catheter
Published
2026-06-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OZTBalloon Aortic Valvuloplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OZTBalloon Aortic ValvuloplastyCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253855000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253855000KardiaPSI Balloon CatheterIntervention Tech, Inc. ; dba Corvention2026-05-06OZT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G825CVPSS19255PackageHIBCC5In Commercial Distribution
G825CVPSI19251PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac valvuloplasty catheterA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Balloon Diameter0

Regulatory Flags#

DUNS number
144872016
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G825CVPSI20251KardiaPSICVPSI2025CVPSI20252026-06-24
G825CVPSI21251KardiaPSICVPSI2125CVPSI21252026-06-24
G825CVPSI22251KardiaPSICVPSI2225CVPSI22252026-06-24
G825CVPSI23251KardiaPSICVPSI2325CVPSI23252026-06-24
G825CVPSI24251KardiaPSICVPSI2425CVPSI24252026-06-24
G825CVPSI25251KardiaPSICVPSI2525CVPSI25252026-06-24
G825CVPSI26251KardiaPSICVPSI2625CVPSI26252026-06-24
G825CVPSI27251KardiaPSICVPSI2725CVPSI27252026-06-24
G825CVPSI28251KardiaPSICVPSI2825CVPSI28252026-06-24
G825CVPSI29251KardiaPSICVPSI2925CVPSI29252026-06-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G825CVPSI20251KardiaPSIIntervention Tech, Inc. dba CorventionOZT2026-06-24
G825CVPSI21251KardiaPSIIntervention Tech, Inc. dba CorventionOZT2026-06-24
G825CVPSI22251KardiaPSIIntervention Tech, Inc. dba CorventionOZT2026-06-24
G825CVPSI23251KardiaPSIIntervention Tech, Inc. dba CorventionOZT2026-06-24
G825CVPSI24251KardiaPSIIntervention Tech, Inc. dba CorventionOZT2026-06-24
G825CVPSI25251KardiaPSIIntervention Tech, Inc. dba CorventionOZT2026-06-24
G825CVPSI26251KardiaPSIIntervention Tech, Inc. dba CorventionOZT2026-06-24
G825CVPSI27251KardiaPSIIntervention Tech, Inc. dba CorventionOZT2026-06-24
G825CVPSI28251KardiaPSIIntervention Tech, Inc. dba CorventionOZT2026-06-24
G825CVPSI29251KardiaPSIIntervention Tech, Inc. dba CorventionOZT2026-06-24
06009698453789OutFlo Aortic Valve Valvuloplasty Dilatation Balloon CatheterDISA MEDINOTEC (PTY) LTDOZT2026-05-20
06009698453796OutFlo Aortic Valve Valvuloplasty Dilatation Balloon CatheterDISA MEDINOTEC (PTY) LTDOZT2026-05-20
06009698453802OutFlo Aortic Valve Valvuloplasty Dilatation Balloon CatheterDISA MEDINOTEC (PTY) LTDOZT2026-05-20
06009698453819OutFlo Aortic Valve Valvuloplasty Dilatation Balloon CatheterDISA MEDINOTEC (PTY) LTDOZT2026-05-20
06009698453826OutFlo Aortic Valve Valvuloplasty Dilatation Balloon CatheterDISA MEDINOTEC (PTY) LTDOZT2026-05-20
06934184005060ValvuloPro®Dongguan TT Medical, Inc.OZT2024-05-10
06934184005077ValvuloPro®Dongguan TT Medical, Inc.OZT2024-05-10
06934184005084ValvuloPro®Dongguan TT Medical, Inc.OZT2024-05-10
06934184005091ValvuloPro®Dongguan TT Medical, Inc.OZT2024-05-10
06934184005107ValvuloPro®Dongguan TT Medical, Inc.OZT2024-05-10
06934184005114ValvuloPro®Dongguan TT Medical, Inc.OZT2024-05-10
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14960685201235INOUE BALLOON ATORAY INDUSTRIES,INC.OZT2023-06-01
14960685201242INOUE BALLOON ATORAY INDUSTRIES,INC.OZT2023-06-01
14960685201259INOUE BALLOON ATORAY INDUSTRIES,INC.OZT2023-06-01
14960685201341INOUE BALLOON ATORAY INDUSTRIES,INC.OZT2023-06-01
14960685201358INOUE BALLOON ATORAY INDUSTRIES,INC.OZT2023-06-01
14960685201389INOUE BALLOON ATORAY INDUSTRIES,INC.OZT2023-06-01
14960685201396INOUE BALLOON ATORAY INDUSTRIES,INC.OZT2023-06-01
14960685201402INOUE BALLOON ATORAY INDUSTRIES,INC.OZT2023-06-01