Hemotec Act High Range Activated Clotting Time

• • Ongoing Z-0539-2026 FDA Class II ·initiated 20 Oct 2025

  Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges.

510(k) Number

K860122 ↗

FDA Product Code

JBP

Device Class

Class II

Regulation

21 CFR Part 864.7140

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• E-Z Up Artherapedic Chair

  Class I

  FDA 510(k) K821651 Active Cleared 24 Jun 1982

• Amicon Diafilter 40. Hemofilter

  Class II

  FDA 510(k) K840449 Active Cleared 23 Mar 1984

• Additional Hemotec Act Coagulation Cartridges

  Class II

  FDA 510(k) K853198 Active Cleared 4 Oct 1985

• Ultrasun 3000 and 5000 Suntanning Unit

  Class II

  FDA 510(k) K860931 Active Cleared 28 Mar 1986

• Swiss Lithoclast Master Handpiece and 3.2 Mm Probe

  Class II

  FDA 510(k) K974164 Active Cleared 18 Dec 1997

• Elcam Stopcocks and Manifolds Open recall

  Class II

  FDA 510(k) K022895 Active Cleared 18 Oct 2002

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