510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953870Substantially Equivalent

Acttrac Electronic Control Device for the Act & Act II Coagulation Instruments

Medtronic, Inc., Parker CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953870 is the FDA 510(k) clearance record for ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTS, a class II device, cleared for Medtronic Vascular on under FDA product code GKN (Timer, Clot, Automated). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K953870.

Clearance record

Decision date
Received
(75 days to decision)
Product code
GKN Timer, Clot, Automated
Regulation
21 CFR 864.5400
Device class
Class II
Review panel
Hematology
Applicant
Medtronic Vascular 18501 E Plz. Dr., Parker CO
510(k) summary
Summary
Third party review
No

Clearances, product code GKN

Trailing 12 months

FDA records hold no clearances under product code GKN in the trailing twelve months.

FDA records show no clearances under product code GKN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GKN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260