Product code GKN— Hematology

ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTS

Classification name: Timer, Clot, Automated
Device class: Class 2
Regulation: 21 CFR 864.5400
Advisory panel: Hematology
Total cleared: 3
First cleared: 1992-06-16
Most recent: 1995-10-31

Market context for product code GKN

FDA has cleared 3 devices under product code GKN between 1992 and 1995, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

19951 clearance
19941 clearance
19921 clearance

Top applicants under product code GKN

Medtronic Vascular1 clearance
Medtronic Hemotec, Inc.1 clearance
Medical Innovations Corp.1 clearance

Recent clearances under product code GKN

K953870 — ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTSMedtronic Vascular·1995-10-31
K940426 — MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMERMedtronic Hemotec, Inc.·1994-09-20
K913320 — MIL CM-II COAGULATION MACHINEMedical Innovations Corp.·1992-06-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.