FDA.reportPublic FDA data

Flex-Ez Stylet Wire Balloon Dilator

Primary DI
M84937400
Brand
Flex-Ez Stylet Wire Balloon Dilator
Company
HOBBS MEDICAL, INC.
Model
3740
Catalog number
3740
Device description
A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically dilate gastrointestinal strictures. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device is multi-lumen with radiopaque markers and is wire-guided. This is a single-use device.
Published
2016-09-21
Public version status
Update
Distribution status
Not 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
KNQDilator, Esophageal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNQDilator, EsophagealGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K834413000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K834413000DILATION BALLOON CATHETERHobbs Medical, Inc.1984-05-22FGE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M84937400PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
8606845875customerservice@hobbsmedical.com

Regulatory Flags#

DUNS number
076769355
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
M84921890CleanCapture Aspiration Catheter218921892026-01-14
M84921891CleanCapture Aspiration Catheter218921892026-01-14
M84960050Hobbs Biliary Amsterdam Stent Kit600560052016-09-21
M84960060Hobbs Biliary Amsterdam Stent Kit600660062016-09-21
M84960090Hobbs Biliary Amsterdam Stent Kit600960092016-09-21
M84960110Hobbs Biliary Amsterdam Stent Kit601160112016-09-21
M84960120Hobbs Biliary Amsterdam Stent Kit601260122016-09-21
M84960130Hobbs Biliary Amsterdam Stent Kit601360132016-09-21
M84960140Hobbs Biliary Amsterdam Stent Kit601460142016-09-21
M84960150Hobbs Biliary Amsterdam Stent Kit601560152016-09-21
M84963100Freeman Pancreatic Flexi-Stent Kit631063102016-09-21
M84963110Freeman Pancreatic Flexi-Stent Kit631163112016-09-21
M84963200Freeman Pancreatic Flexi-Stent Kit632063202016-09-21
M84963210Freeman Pancreatic Flexi-Stent Kit632163212016-09-21
M84965010Freeman Pancreatic Flexi-Stent Kit650165012016-09-21
M84965020Freeman Pancreatic Flexi-Stent Kit650265022016-09-21
M84965030Freeman Pancreatic Flexi-Stent Kit650365032016-09-21
M84965040Freeman Pancreatic Flexi-Stent Kit650465042016-09-21
M84965050Freeman Pancreatic Flexi-Stent Kit650565052016-09-21
M84965060Freeman Pancreatic Flexi-Stent Kit650665062016-09-21

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Primary DI, Brand, Company table
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