FDA.report

510(k) K230248

Device
VIOLA
Applicant
Vascular Graft Solutions, Ltd.
510(k) number
K230248
Product code
DXC
Decision
Substantially Equivalent (SESE)
Decision date
2023-02-28
Date received
2023-01-30
Regulation
870.4450
Classification name
Clamp, Vascular
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Orit Yarden
Address
24 Raoul Wallenberg St. Tel Aviv IL 6971921 6971921

FDA Registration Numbers

Source Documents

510(k) summary PDF

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