FDA.reportPublic FDA data

Reliant(TM) Multistage Dilatation Balloon Catheter

Primary DI
06932503523110
Brand
Reliant(TM) Multistage Dilatation Balloon Catheter
Company
Micro-Tech (Nanjing) Co., Ltd.
Model
MBD-CM-BB-2
Catalog number
MBD-CM-BB-2
Device description
the balloon diameter is 10-11-12mm,the balloon length is 55mm,the catheter diameter is 7 Fr., and the working length is 2300mm,with stainless steel guide wire
Published
2016-03-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FGECatheter, Biliary, Diagnostic
KNQDilator, Esophageal

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180418000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180418000Reliant(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.2018-10-15FGE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06932503523110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06932503523110069325035231106932503523110

GMDN Terms#

Term, Definition table
TermDefinition
Oesophageal balloon catheterA long, flexible device with an inflatable balloon(s) at its distal end designed to access the length of the oesophagus of adult and adolescent patients to dilate strictures through balloon inflation. It is typically constructed as a catheter of various designs and is usually used endoscopically to enable visualization during the procedure. It is typically used to dilate strictures due to oesophageal surgery, primary gastric reflux, radiation therapy, and dilatation of the cardia in patients with achalasia (failure to relax the lower oesophageal sphincter). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Balloon Length55Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-552-4027info@micro-tech-usa.com

Regulatory Flags#

DUNS number
530269083
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06932503540353Disposable Biopsy Forceps1005751005752020-03-23
06932503540360Disposable Biopsy Forceps1005761005762020-03-23
06932503540377Disposable Biopsy Forceps1005771005772020-03-23
06932503540384Disposable Biopsy Forceps1005781005782020-03-23
06932503510219Pulmonary Hydro-Slide GuidewireGW-35/182026-05-29
06932503510226Pulmonary Hydro-Slide GuidewireGW-35/262026-05-29
06932503563772eyeMAX(TM) Single-use Video Pancreaticobiliary ScopeCDS220092026-05-15
06932503516112Sphincterotome / short-wire compatibleRDSP-0525-121-12026-05-08
06932503516129Sphincterotome / short-wire compatibleRDSP-0525-221-12026-05-08
06932503516136Sphincterotome / short-wire compatibleRDSP-0525-131-12026-05-08
06932503516143Sphincterotome / short-wire compatibleRDSP-0525-231-12026-05-08
06932503516150Sphincterotome / short-wire compatibleRDSP-0530-111-12026-05-08
06932503516167Sphincterotome / short-wire compatibleRDSP-0530-211-12026-05-08
06932503516174Sphincterotome / short-wire compatibleRDSP-0530-121-12026-05-08
06932503516181Sphincterotome / short-wire compatibleRDSP-0530-221-12026-05-08
06932503516198Sphincterotome / short-wire compatibleRDSP-0530-131-12026-05-08
06932503516204Sphincterotome / short-wire compatibleRDSP-0530-231-12026-05-08
06932503575379Sphincterotome / short-wire compatibleRDSP-0220-1112026-05-08
06932503575386Sphincterotome / short-wire compatibleRDSP-0220-2112026-05-08
06932503575393Sphincterotome / short-wire compatibleRDSP-0220-1212026-05-08

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
08714729163039XXL™ EsophagealBOSTON SCIENTIFIC CORPORATIONKNQ2016-09-24
08714729163053XXL™ EsophagealBOSTON SCIENTIFIC CORPORATIONKNQ2016-09-24
08714729163060XXL™ EsophagealBOSTON SCIENTIFIC CORPORATIONKNQ2016-09-24
08714729163084XXL™ EsophagealBOSTON SCIENTIFIC CORPORATIONKNQ2016-09-24
08714729163114XXL™ EsophagealBOSTON SCIENTIFIC CORPORATIONKNQ2016-09-24
08714729163121XXL™ EsophagealBOSTON SCIENTIFIC CORPORATIONKNQ2016-09-24
08714729163145XXL™ EsophagealBOSTON SCIENTIFIC CORPORATIONKNQ2016-09-24
08714729163169XXL™ EsophagealBOSTON SCIENTIFIC CORPORATIONKNQ2016-09-24
08714729163176XXL™ EsophagealBOSTON SCIENTIFIC CORPORATIONKNQ2016-09-24
08714729163190XXL™ EsophagealBOSTON SCIENTIFIC CORPORATIONKNQ2016-09-24
08714729195986CRE Fixed WireBOSTON SCIENTIFIC CORPORATIONKNQ2016-09-24
08714729195993CRE Fixed WireBOSTON SCIENTIFIC CORPORATIONKNQ2016-09-24
08714729202011CRE Fixed WireBOSTON SCIENTIFIC CORPORATIONKNQ2016-09-24
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