FDA.reportPublic FDA data

23MM X 4CM X 130CM EDWARDS BALLOON CATHETER

Primary DI
00690103191820
Brand
23MM X 4CM X 130CM EDWARDS BALLOON CATHETER
Company
Edwards Lifesciences LLC
Model
9350BC23
Catalog number
9350BC23A
Device description
EDWARDS BALLOON CATHETER
Published
2015-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OMZPulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter
OZTBalloon aortic valvuloplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMZPulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty CatheterCardiovascular2
OZTBalloon Aortic ValvuloplastyCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140241000
K153069000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140241000EDWARDS TRANSFEMORAL BALLOON CATHETEREdwards Lifesciences, LLC2014-07-03OZT
K153069000Edwards Balloon CatheterEdwards Lifesciences2016-01-07OMZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00690103191820PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690103191820006901031918206901031918200690103191820

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
Special Storage Condition, Specify00STORE IN A COOL, DRY PLACE

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)822-9637tech_support@edwards.com

Regulatory Flags#

DUNS number
134139174
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00690103220223TRIFORMIS RESILIA Tricuspid Valve11300T2511300T252026-05-28
00690103220230TRIFORMIS RESILIA Tricuspid Valve11300T2711300T272026-05-28
00690103220247TRIFORMIS RESILIA Tricuspid Valve11300T2911300T292026-05-28
00690103220254TRIFORMIS RESILIA Tricuspid Valve11300T3111300T312026-05-28
00690103220261TRIFORMIS RESILIA Tricuspid Valve11300T3311300T332026-05-28
00690103019643HEART VALVE ACCESSORY1170117019MM2026-04-06
00690103019650HEART VALVE ACCESSORY1170117021MM2026-04-06
00690103019674HEART VALVE ACCESSORY1170117025MM2026-04-06
00690103019698HEART VALVE ACCESSORY1170117029MM2026-04-06
00690103019704HEART VALVE ACCESSORY1174M1174M242026-04-06
00690103019711HEART VALVE ACCESSORY1174M1174M262026-04-06
00690103019728HEART VALVE ACCESSORY1174M1174M282026-04-06
00690103019735HEART VALVE ACCESSORY1174M1174M302026-04-06
00690103019742HEART VALVE ACCESSORY1174M1174M322026-04-06
00690103019759HEART VALVE ACCESSORY1174M1174M342026-04-06
00690103019766HEART VALVE ACCESSORY1174M1174M362026-04-06
00690103019773HEART VALVE ACCESSORY1174M1174M382026-04-06
00690103019780HEART VALVE ACCESSORY1174M1174M402026-04-06
00690103019797HEART VALVE ACCESSORY1175T1175T262026-04-06
00690103019803HEART VALVE ACCESSORY1175T1175T282026-04-06

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