Home / 510(k) Clearances / K940426

510(k) K940426

MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER by Medtronic Hemotec, Inc. — Product Code GKN

K940426 is an FDA 510(k) premarket notification submitted by Medtronic Hemotec, Inc. for the device "MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER". The FDA issued a decision of Substantially Equivalent on September 20, 1994. The device falls under product code GKN (Timer, Clot, Automated), a Class II device regulated under 21 CFR 864.5400. Medtronic Hemotec, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1994
Date Received
January 31, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Timer, Clot, Automated
Device Class
Class II
Regulation Number
864.5400
Review Panel
HE
Submission Type

Other clearances by Medtronic Hemotec, Inc.

  • K954202 — PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS (June 20, 1996)
  • K944115 — HEPARIN ASSAY CARTRIDGES AND CONTROLS (March 24, 1995)
  • K923594 — CLOTTRAC COAGULATION CONTROL (September 21, 1992)
  • K922031 — HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL (July 21, 1992)

Other clearances for product code GKN

  • K953870 — ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTS (October 31, 1995)
  • K913320 — MIL CM-II COAGULATION MACHINE (June 16, 1992)

FDA data resources