FDA.reportPublic FDA data

V8

Primary DI
00859945004136
Brand
V8
Company
INTERVALVE INC
Model
V8-2328
Catalog number
V8-2328
Device description
V8 Balloon Aortic Valvuloplasty Catheter, V8-2328
Published
2016-09-08
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
OZTBalloon Aortic Valvuloplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OZTBalloon Aortic ValvuloplastyCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859945004136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859945004136008599450041368599450041360859945004136

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
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6123969849spetrie@libramed.com

Regulatory Flags#

DUNS number
037375827
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859945004068V8172212C110172212C1102016-09-08
00859945004075V8192412C110192412C1102016-09-08
00859945004082V8212612C110212612C1102016-09-08
00859945004099V8232812C110232812C1102016-09-08
00859945004105V8V8-1722V8-17222016-09-08
00859945004112V8V8-1924V8-19242016-09-08
00859945004129V8V8-2126V8-21262016-09-08
00859945004143V8TAV8-1722TAV8-17222016-09-08
00859945004150V8TAV8-1924TAV8-19242016-09-08
00859945004167V8TAV8-2126TAV8-21262016-09-08
00859945004174V8TAV8-2328TAV8-23282016-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
14960685201228INOUE BALLOON ATORAY INDUSTRIES,INC.OZT2023-06-01
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
14960685201419INOUE BALLOON ATORAY INDUSTRIES,INC.OZT2023-06-01
14960685201426INOUE BALLOON ATORAY INDUSTRIES,INC.OZT2023-06-01
14960685201433INOUE BALLOON ATORAY INDUSTRIES,INC.OZT2023-06-01
04046964555077Z-MED™B BRAUN INTERVENTIONAL SYSTEMS, INCOZT2016-09-23
04046964555084Z-MED™B BRAUN INTERVENTIONAL SYSTEMS, INCOZT2016-09-23
04046964555664Z-MED™B BRAUN INTERVENTIONAL SYSTEMS, INCOZT2016-09-23
04046964555091Z-MED™B BRAUN INTERVENTIONAL SYSTEMS, INCOZT2016-09-23
04046964340024NuCLEUS-X™B BRAUN INTERVENTIONAL SYSTEMS, INCOZT2016-09-21
04046964340062NuCLEUS-X™B BRAUN INTERVENTIONAL SYSTEMS, INCOZT2016-09-21
04046964340086NuCLEUS-X™B BRAUN INTERVENTIONAL SYSTEMS, INCOZT2016-09-21