Clearance Summary
ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTS received FDA 510(k) clearance under submission number K953870, sponsored by Medtronic Vascular. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1995-10-31.
- Submission: K953870
- Applicant / Sponsor: Medtronic Vascular
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5400
- Decision date: 1995-10-31
Classification & Regulation
This clearance is catalogued under FDA product code GKN and 21 CFR 864.5400, within the Hematology review panel as a Class II device.