FDA.reportPublic FDA data

Disposable Sure-Flex Balloon Dilatation Catheter

Primary DI
00813353010059
Brand
Disposable Sure-Flex Balloon Dilatation Catheter
Company
Telemed Systems
Model
1008
Device description
Esophageal Dilator16mm Diameter x 4cm Length Balloon Dimension200cm Total Catheter Length
Published
2023-07-12
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
KNQDilator, Esophageal

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K901424000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K901424000ESOPHAGEAL BALLOON DILATORTelemed Systems, Inc.1990-06-21KNQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813353010059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813353010059008133530100598133530100590813353010059

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic gastrointestinal stenosis dilatorA sterile invasive device intended to be used to dilate or expand a narrowing lesion (e.g., oesophageal stricture, stenosis) in the lumen of the gastrointestinal [GI] tract, under endoscopic visualization. It is made of transparent synthetic polymer material and is available in various forms (e.g., a slender hollow tube through which is passed the endoscope before introduction into the GI tract, or a tapered cap applied to the distal end of the endoscope); the dilator is advanced through the lesion site with direct visualization through the endoscope. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
017939239
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813353010080Disposable Sure-Flex Biliary Balloon Dilatation Catheter13422023-07-12
00813353010097Disposable Sure-Flex Biliary Balloon Dilatation Catheter13442023-07-12
00813353010103Disposable Sure-Flex Biliary Balloon Dilatation Catheter13462023-07-12
00813353010110Disposable Progressive Pressure Dilators14152023-07-12
00813353010127Disposable Progressive Pressure Dilators14182023-07-12
00813353010196Disposable Sclerotherapy Needle20022023-08-24
00813353010202Disposable Sclerotherapy Needle20042023-08-24
00813353010219Disposable Sclerotherapy Needle20062023-08-24
00813353010226Disposable Sclerotherapy Needle20082023-08-24
00813353010233Disposable Sclerotherapy Needle20102023-08-24
00813353010240Disposable Sclerotherapy Needle20142023-08-24
00813353010257Disposable Sclerotherapy Needle20152023-08-24
00813353010264Disposable Sclerotherapy Needle20162023-08-24
00813353010271Disposable Sclerotherapy Needle20182023-08-24
00813353010288Disposable Transbronchial Needle21022023-08-24
00813353010295Disposable Gastrointestinal Cytology Brush30022023-08-24
00813353010301Disposable Gastrointestinal Cytology Brush30042023-08-24
00813353010318Disposable Gastrointestinal Cytology Brush30062023-08-24
00813353010325Disposable Gastrointestinal Cytology Brush30082023-08-24
00813353010332Disposable Gastrointestinal Cytology Brush30102023-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664925645NAHangzhou AGS MedTech Co., Ltd.KNQ2026-06-18
06959664925676NAHangzhou AGS MedTech Co., Ltd.KNQ2026-06-18
06959664925584NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664925614NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664925959NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664925980NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926017NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926048NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926314NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926345NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926376NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926406NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926673NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926703NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926734NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926765NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664927038NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664927069NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664927090NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664927120NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664927403NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664927434NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664927465NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664927496NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664928943NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664928974NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664929001NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664929032NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664929070NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664929100NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15