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510(k) Data Aggregation
K Number
K210681Device Name
SiteSeal SV
Manufacturer
Ensite Vascular
Date Cleared
2021-04-06
(29 days)
Product Code
DXC
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
Ensite Vascular
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SiteSeal SV is a compression device to assist hemostasis of the radial artery after a transradial procedure or the brachial artery after a transbrachial procedure.
Device Description
Not Found
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K Number
K190351Device Name
Site Seal SV
Manufacturer
Ensite Vascular
Date Cleared
2019-07-02
(138 days)
Product Code
DXC
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
Ensite Vascular
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SiteSeal SV is a compression device to assist hemostasis of the radial artery after a transradial procedure.
Device Description
The SiteSeal SV is a compression device to assist hemostasis of the radial artery after a transradial procedure.
Ask a Question
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