ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTS— 510(k) K953870

Name: FDA 510(k) clearance K953870
Creator: U.S. Food and Drug Administration
Published: 1995-10-31

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K953870 for ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTS, Substantially Equivalent on 1995-10-31. Applicant: Medtronic Vascular. Device class: 2.

Clearance details

Applicant: Medtronic Vascular
Product code: Code GKN
Device class: Class 2
Regulation: 21 CFR 864.5400
Advisory panel: Hematology
Date received: 1995-08-17
Decision date: 1995-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parker, CO, US

Download summary PDF View on FDA.gov ↗

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