FDA.reportPublic FDA data

TRUE DILATATION

Primary DI
00801741090998
Brand
TRUE DILATATION
Company
Bard Peripheral Vascular, Inc.
Model
0204511
Catalog number
0204511
Device description
TRUE™ DILATATION Balloon Valvuloplasty Catheter, 20 mm x 4.5 cm, 110 cm catheter
Published
2016-09-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
00801741090998PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741090998008017410909988017410909980801741090998

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)321-4254medical.services@crbard.com

Regulatory Flags#

DUNS number
135057938
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741234187EnCor EnCompass™ENCPBagENCPBag2026-02-09
10801741234153EnCor EnCompass™ENCPSCENCPSC2026-02-04
10801741234160EnCor EnCompass™ENCPMRIXENCPMRIX2026-02-04
00801741236167EnCor EnCompass™ENCP10GVLOCENCP10GVLOC2026-02-04
00801741234194EnCor EnCompass™ENCPSTENCPST2026-02-03
00801741234248EnCor EnCompass™ENCPDriverENCPDriver2026-02-03
00801741234262EnCor EnCompass™ENCPFSENCPFS2026-02-03
00801741235221EnCor EnCompass™ENCPConsoleENCPConsole2026-02-03
10801741234092EnCor EnCompass™ENCP7GENCP7G2026-01-30
10801741234139EnCor EnCompass™ENCP7GBTENCP7GBT2026-01-30
00801741234200EnCor EnCompass™ENCP7GVLOCENCP7GVLOC2026-01-30
10801741234115EnCor EnCompass™ENCP12GENCP12G2026-01-28
10801741234146EnCor EnCompass™ENCP10GBTENCP10GBT2026-01-28
10801741234177EnCor EnCompass™ENCP10GENCP10G2026-01-28
10801741226332UltraCor™ Twirl™UCLS17UCLS172025-04-01
10801741226349UltraCor™ Twirl™UCVR17UCVR172025-04-01
10801741230605PeritX90-201090-20102025-01-23
10801741230612PeritX90-200590-20052025-01-23
10801741230636PeritX90-202090-20202025-01-23
50885403464032JamshidiEJC3513EJC35132017-10-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
04046964340048NuCLEUS-X™B BRAUN INTERVENTIONAL SYSTEMS, INCOZT2016-09-21
04046964340161NuCLEUS-X™B BRAUN INTERVENTIONAL SYSTEMS, INCOZT2016-09-21
04046964340185NuCLEUS-X™B BRAUN INTERVENTIONAL SYSTEMS, INCOZT2016-09-21
04046964340208NuCLEUS-X™B BRAUN INTERVENTIONAL SYSTEMS, INCOZT2016-09-21
04046964340246NuCLEUS-X™B BRAUN INTERVENTIONAL SYSTEMS, INCOZT2016-09-21
04046964340291NuCLEUS-X™B BRAUN INTERVENTIONAL SYSTEMS, INCOZT2016-09-21
04046964340307NuCLEUS-X™B BRAUN INTERVENTIONAL SYSTEMS, INCOZT2016-09-21
04046964340321NuCLEUS-X™B BRAUN INTERVENTIONAL SYSTEMS, INCOZT2016-09-21
00801741127854VIDA®Bard Peripheral Vascular, Inc.OZT2016-09-16
00801741127861VIDA®Bard Peripheral Vascular, Inc.OZT2016-09-16
00801741127878VIDA®Bard Peripheral Vascular, Inc.OZT2016-09-16
00801741127885VIDA®Bard Peripheral Vascular, Inc.OZT2016-09-16