FDA.reportPublic FDA data

Single-use Balloon Dilatation Catheter

Primary DI
06941112337285
Brand
Single-use Balloon Dilatation Catheter
Company
Leo Medical Co., Ltd.
Model
KZ0855H3
Catalog number
KZ0855H3
Published
2026-01-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FGEStents, Drains And Dilators For The Biliary Ducts

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGEStents, Drains And Dilators For The Biliary DuctsGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241888000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241888000Single-use Balloon Dilatation CatheterLeo Medical Co., Ltd.2024-12-20FGE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06941112337285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06941112337285069411123372856941112337285

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal/biliary dilation balloon catheter, non-medicatedA long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, may be of the fixed-wire or wire-guided type, and is not coated with a drug/pharmaceutical. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421371962
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06923646504029Single-use Balloon Dilatation CatheterKZ0630E0KZ0630E02026-01-04
06923646504036Single-use Balloon Dilatation CatheterKZ0830E0KZ0830E02026-01-04
06923646504043Single-use Balloon Dilatation CatheterKZ1030E0KZ1030E02026-01-04
06923646504050Single-use Balloon Dilatation CatheterKZ1230E0KZ1230E02026-01-04
06923646504067Single-use Balloon Dilatation CatheterKZ1530E0KZ1530E02026-01-04
06923646504074Single-use Balloon Dilatation CatheterKZ0680F0KZ0680F02026-01-04
06923646504081Single-use Balloon Dilatation CatheterKZ0880F0KZ0880F02026-01-04
06923646504098Single-use Balloon Dilatation CatheterKZ1080F0KZ1080F02026-01-04
06923646504104Single-use Balloon Dilatation CatheterKZ1280F0KZ1280F02026-01-04
06923646504111Single-use Balloon Dilatation CatheterKZ1580F0KZ1580F02026-01-04
06923646504128Single-use Balloon Dilatation CatheterKZ1880F0KZ1880F02026-01-04
06923646504258Single-use Balloon Dilatation CatheterKZ0655H0KZ0655H02026-01-04
06923646504265Single-use Balloon Dilatation CatheterKZ0855H0KZ0855H02026-01-04
06923646504272Single-use Balloon Dilatation CatheterKZ1055H0KZ1055H02026-01-04
06923646504289Single-use Balloon Dilatation CatheterKZ1255H0KZ1255H02026-01-04
06923646504296Single-use Balloon Dilatation CatheterKZ1555H0KZ1555H02026-01-04
06923646504302Single-use Balloon Dilatation CatheterKZ1855H0KZ1855H02026-01-04
06923646504388Single-use Balloon Dilatation CatheterKZ0655G0KZ0655G02026-01-04
06923646504395Single-use Balloon Dilatation CatheterKZ0855G0KZ0855G02026-01-04
06923646504401Single-use Balloon Dilatation CatheterKZ1055G0KZ1055G02026-01-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15711055100400M-DrainMermaid Medical A/SFGE2024-10-01
15711055110041M-DrainMermaid Medical A/SFGE2024-07-20
15711055110409M-DrainMermaid Medical A/SFGE2024-07-20
15711055120040M-DrainMermaid Medical A/SFGE2024-01-31
15711055120453M-DrainMermaid Medical A/SFGE2024-01-31
15711055000311M-DrainMermaid Medical A/SFGE2016-09-24
15711055000328M-DrainMermaid Medical A/SFGE2016-09-24
15711055000359M-DrainMermaid Medical A/SFGE2016-09-24
15711055000373M-DrainMermaid Medical A/SFGE2016-09-24
15711055000410M-DrainMermaid Medical A/SFGE2016-09-24
15711055000434M-DrainMermaid Medical A/SFGE2016-09-24
15711055000458M-DrainMermaid Medical A/SFGE2016-09-24
15711055000472M-DrainMermaid Medical A/SFGE2016-09-24
15711055000496M-DrainMermaid Medical A/SFGE2016-09-24
15711055000519M-DrainMermaid Medical A/SFGE2016-09-24
15711055000533M-DrainMermaid Medical A/SFGE2016-09-24
15711055000557M-DrainMermaid Medical A/SFGE2016-09-24
15711055000588M-DrainMermaid Medical A/SFGE2016-09-24
15711055000595M-DrainMermaid Medical A/SFGE2016-09-24
15711055000625M-DrainMermaid Medical A/SFGE2016-09-24
15711055000632M-DrainMermaid Medical A/SFGE2016-09-24
15711055000663M-DrainMermaid Medical A/SFGE2016-09-24
15711055000670M-DrainMermaid Medical A/SFGE2016-09-24
15711055000700M-DrainMermaid Medical A/SFGE2016-09-24
15711055000724M-DrainMermaid Medical A/SFGE2016-09-24
15711055000748M-DrainMermaid Medical A/SFGE2016-09-24
15711055000762M-DrainMermaid Medical A/SFGE2016-09-24
15711055000779M-DrainMermaid Medical A/SFGE2016-09-24
15711055000809M-DrainMermaid Medical A/SFGE2016-09-24
15711055000816M-DrainMermaid Medical A/SFGE2016-09-24