Clearance Summary
HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR received FDA 510(k) clearance under submission number K051040, sponsored by Medtronic Perfusion Systems. The device was reviewed via the Special premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2005-05-24.
- Submission: K051040
- Applicant / Sponsor: Medtronic Perfusion Systems
- Clearance pathway: Special
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5680
- Decision date: 2005-05-24
Classification & Regulation
This clearance is catalogued under FDA product code JOX and 21 CFR 864.5680, within the Hematology review panel as a Class II device.