FDA.report

510(k) K210681

Device
SiteSeal SV
Applicant
Ensite Vascular
510(k) number
K210681
Product code
DXC
Decision
Substantially Equivalent (SESE)
Decision date
2021-04-06
Date received
2021-03-08
Regulation
870.4450
Classification name
Clamp, Vascular
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Statement
Third party reviewed
N

Related Records

Applicant Contact

Contact
Thomas Reidy
Address
10900 S. Clay Blair Blvd. Olathe KS US 66061 66061

FDA Registration Numbers

Source Documents

510(k) summary PDF not indicated by FDA

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