FDA.reportPublic FDA data

ValvuloPro®

Primary DI
06934184005084
Brand
ValvuloPro®
Company
Dongguan TT Medical, Inc.
Model
VBC2140
Published
2024-05-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K231814000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231814000ValvuloPro Valvuloplasty Balloon CatheterDongguan TT Medical, Inc.2023-10-12OZT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06934184005084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06934184005084069341840050846934184005084

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
551476865
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06934184004100MultiStage®MSO-0630-082025-02-10
06934184004117MultiStage®MSW-0830-082025-02-10
06934184004124MultiStage®MSO-1030-082025-02-10
06934184004131MultiStage®MSO-1230-082025-02-10
06934184004148MultiStage®MSO-1530-082025-02-10
06934184004155MultiStage®MSO-1830-082025-02-10
06934184004162MultiStage®MSO-0630-172025-02-10
06934184004179MultiStage®MSO-0830-172025-02-10
06934184004186MultiStage®MSO-1030-172025-02-10
06934184004193MultiStage®MSO-1230-172025-02-10
06934184004209MultiStage®MSO-1530-172025-02-10
06934184004216MultiStage®MSO-1830-172025-02-10
06934184004223MultiStage®MSO-0630-232025-02-10
06934184004230MultiStage®MSO-0830-232025-02-10
06934184004254MultiStage®MSO-1230-232025-02-10
06934184004261MultiStage®MSO-1530-232025-02-10
06934184004278MultiStage®MSO-1830-232025-02-10
06934184004285MultiStage®MSO-0655-082025-02-10
06934184004292MultiStage®MSO-0855-082025-02-10
06934184004308MultiStage®MSO-1055-082025-02-10

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
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
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