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510(k) K190351

Device
Site Seal SV
Applicant
Ensite Vascular
510(k) number
K190351
Product code
DXC  
Decision
Substantially Equivalent (SESE)
Decision date
2019-07-02
Date received
2019-02-14
Regulation
870.4450
Classification name
Clamp, Vascular
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Thomas Reidy
Address
10900 S. Clay Blair Blvd., Suite 800 Olathe KS US 66061 66061

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DXC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252772Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc.2026-05-22
K254060Life Saving TourniquetTW Medical2026-04-03
K243627Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)Arc Trauma, LLC2025-12-31
K253070Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)Medline Industries, LP2025-11-20
K232577Radial Compression DeviceNingbo Dizegens Medical Science Co.,Ltd2024-01-18
K230281PICOCLAMPKono Seisakusho Co., Ltd.2023-10-23
K221661Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)Compression Works, Inc.2023-03-03
K230248VIOLAVascular Graft Solutions, Ltd.2023-02-28
K222182Radial Artery Compression TourniquetsBeijing Demax Medical Technology Co.,Ltd2023-01-04
K221843GEM Biover Microvascular ClampsSynovis Micro Companies Alliance, Inc.2022-09-14
K213531TR BAND Radial Compression DeviceTerumo Medical Corporation2021-12-20
K210681SiteSeal SVEnsite Vascular2021-04-06
K210324V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186Carefusion 2200, Inc.2021-03-04
K210006MI DeTACHBiorep Technologies, Inc.2021-03-04
K203307VIOLAVascular Graft Solutions, Ltd.2021-02-17

Legacy Summary#

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FDA Review#

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