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Femostop II

by Radi Medical Systems AB 510(k)

Active United States

510(k) K944259

Overview

The Femostop II is a vascular clamp device used for compression of femoral arteries. It is designed to provide hemostasis following catheterization procedures in the femoral artery. The device consists of a compression arch, pump, and bilateral adapter components.

The Femostop II is supplied as a disposable set and is intended for single-use applications. It is classified under product code DXC as a Class II cardiovascular device with special controls. The device received FDA 510(k) clearance on July 20, 1995, with K number K944259.

AI-generated from registry data, 26 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK944259 Date20 Jul 1995ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DXC
Device Class
Class II
Regulation
21 CFR Part 870.4450
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Femostop II used for?

    The Femostop II is a vascular clamp device designed specifically for compression of femoral arteries to provide hemostasis following catheterization procedures in the femoral artery.

  • How is the Femostop II supplied?

    The Femostop II is supplied as a disposable set and is intended for single-use applications only. It comes with a compression arch, pump, and bilateral adapter components.

  • What is the regulatory classification of the Femostop II?

    The Femostop II is classified under product code DXC as a Class II cardiovascular device with special controls. It received FDA 510(k) clearance on July 20, 1995, with K number K944259.

  • Is the Femostop II reusable?

    No, the Femostop II is supplied as a disposable set and is intended for single-use applications only. It should not be reused on multiple patients.