FDA.report

510(k) K254060

Device
Life Saving Tourniquet
Applicant
TW Medical
510(k) number
K254060
Product code
DXC
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-03
Date received
2025-12-17
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

Related Records

Applicant Contact

Contact
Yaakov Tsadik
Address
149 Revava St. Otniel IL 9040700 9040700

FDA Registration Numbers

Source Documents

510(k) summary PDF

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