Femostop II Plus Disposable Set Model 11166, Femostop II Plus Compression Arch Model 11168, Femostop II Bilateral ADAPT0

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K982182 ↗

FDA Product Code

DXC

Models / Variants

11166

Femostop Ii Plus Compression Arch Model 11168

Femostop Ii Bilateral ADAPT0

Device Class

Class II

Regulation

21 CFR Part 870.4450

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Radianalyzer, Model 12710

  Class II

  FDA 510(k) K022188 Active Cleared 3 Oct 2002

• Femostop, Femostop Pump

  Class II

  FDA 510(k) K954669 Active Cleared 27 Oct 1995

• Radianalyzer, Model 12710, Radiview (Pc-Software Accessory), Model 12720

  Class II

  FDA 510(k) K013943 Active Cleared 18 Dec 2001

• Femostop Femoral Compression System

  Class II

  FDA 510(k) K024107 Active Cleared 24 Dec 2002

• Quantien Measurement System

  Class II

  FDA 510(k) K123984 Active Cleared 28 Mar 2013

• Pressure Wire Sensor .014, Pressure Wire Interface 10, Pressure Wire Monitor Cable

  Class II

  FDA 510(k) K972793 Active Cleared 24 Apr 1998

See all devices from Radi Medical Systems AB →