FDA.reportPublic FDA data

ValvuloPro®

Primary DI
06934184005091
Brand
ValvuloPro®
Company
Dongguan TT Medical, Inc.
Model
VBC2340
Published
2024-05-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
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
06934184005091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06934184005091069341840050916934184005091

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
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
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
06934184005060ValvuloPro®Dongguan TT Medical, Inc.OZT2024-05-10
06934184005077ValvuloPro®Dongguan TT Medical, Inc.OZT2024-05-10
06934184005084ValvuloPro®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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