FDA.reportPublic FDA data

VedDilator; 3-Stage Balloon Dilation Catheter

Primary DI
16941513203599
Brand
VedDilator; 3-Stage Balloon Dilation Catheter
Company
Jiangsu Vedkang Medical Science and Technology Co.,Ltd.
Model
VDK-TBD-15/16.5/18-60-120
Published
2024-08-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
K232245000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232245000VedDilator ^TM (3-Stage Balloon Dilation Catheter)Jiangsu Vedkang Medical Science and Technology Co., Ltd.2024-02-15FGE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16941513203599PackageGS11In Commercial Distribution
56941513203597PackageGS110In Commercial Distribution
06941513203592PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694151320359916941513203599
5694151320359756941513203597
06941513203592069415132035926941513203592

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal/biliary dilation balloon catheterA 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, and may be of the fixed-wire or wire-guided type. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544430136
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06941513200089Disposable Non-electric Biopsy ForcepsVDK-FB-30-230-O-P1-B12026-05-22
06941513222692Disposable Non-electric Biopsy ForcepsVDK-FB-23-230-O-P-A22026-05-22
06941513222708Disposable Non-electric Biopsy ForcepsVDK-FB-23-230-O-P1-A22026-05-22
06941513222715Disposable Non-electric Biopsy ForcepsVDK-FB-23-230-W-P-A22026-05-22
06941513222722Disposable Non-electric Biopsy ForcepsVDK-FB-23-230-W-P1-A22026-05-22
06970057578248Disposable Cleaning BrushVDK-CB-06-230-C2026-05-22
06970057578286Polyp TrapsVDK-PT-052026-05-22
06970057579023Disposable Grasping ForcepsVDK-FG-23-230-A12026-05-22
06970057571027Stone Extraction BalloonVDK-BAL-23-11/13/15-B2026-04-14
06970057577937Disposable SphincterotomeVDK-KE-3025110-A2026-04-14
06970057579061Disposable Grasping ForcepsVDK-FG-23-230-A42026-03-25
06970057573014VedBasket, Stone Extraction BasketsVDK-BAS-23-200-30-S4-A2024-08-20
06970057575032Disposable Polyp SnareVDK-SD-23-230-35-A12024-08-20
06970057578040Disposable Endoscopic HemoclipVDK-CD-13-230-P2024-08-20
06970057578118Disposable Endoscopic HemoclipVDK-CD-16-230-P2024-08-20
06970057573021VedBasket, Stone Extraction BasketsVDK-BAS-23-200-35-S4-A2024-08-20
06970057578002Disposable Endoscopic HemoclipVDK-CD-11-230-P2024-08-20
06970057574486Disposable Non-electric Biopsy ForcepsVDK-FB-23-230-W-P1-A12025-05-19
16970057574483Disposable Non-electric Biopsy ForcepsVDK-FB-23-230-W-P1-A12025-05-19
06941513210972Disposable Non-electric Biopsy ForcepsVDK-FB-18-70-O-P-B12025-02-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664925645NAHangzhou AGS MedTech Co., Ltd.KNQ2026-06-18
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