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510(k) K232245

Device
VedDilator ^TM (3-Stage Balloon Dilation Catheter)
Applicant
Jiangsu Vedkang Medical Science and Technology Co., Ltd.
510(k) number
K232245
Product code
FGE
Decision
Substantially Equivalent (SESE)
Decision date
2024-02-15
Date received
2023-07-28
Regulation
876.5010
Classification name
Stents, Drains And Dilators For The Biliary Ducts
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Bao Tian
Address
#52, Guoxiang Rd., Wujin Economic Development Zone Changzhou CN 213149 213149

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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