FDA.reportPublic FDA data

Reliant(TM) Multistage Dilatation Balloon Catheter

Primary DI
16932503523223
Brand
Reliant(TM) Multistage Dilatation Balloon Catheter
Company
Micro-Tech (Nanjing) Co., Ltd.
Model
MBD-FM-BB-2
Catalog number
MBD-FM-BB-2
Device description
the balloon diameter is 18-19-20mm,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
26932503523220PackageGS11In Commercial Distribution
16932503523223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2693250352322026932503523220
1693250352322316932503523223

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Balloon Length55Millimeter

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
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
06932503575409Sphincterotome / short-wire compatibleRDSP-0220-2212026-05-08
06932503575416Sphincterotome / short-wire compatibleRDSP-0220-1312026-05-08
06932503575423Sphincterotome / short-wire compatibleRDSP-0220-2312026-05-08
06932503575430Sphincterotome / short-wire compatibleRDSP-0225-1112026-05-08
06932503575447Sphincterotome / short-wire compatibleRDSP-0225-2112026-05-08
06932503575454Sphincterotome / short-wire compatibleRDSP-0225-1212026-05-08

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