FDA.reportPublic FDA data

510(k) K252772

Device
Arc Adjustable Radial Cuff Compression Device
Applicant
Tz Medical, Inc.
510(k) number
K252772
Product code
DXC
Decision
Substantially Equivalent (SESE)
Decision date
2026-05-22
Date received
2025-09-02
Regulation
870.4450
Classification name
Clamp, Vascular
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
John Lubisich
Address
20497 SW Teton Ave. Tualatin OR US 97062 97062

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DXC#

510(k), Device, Applicant table
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K210006MI DeTACHBiorep Technologies, Inc.2021-03-04
K203307VIOLAVascular Graft Solutions, Ltd.2021-02-17
K203803VASOBand Vascular Compression DeviceVasoinnovations, Inc.2021-01-26