Clearance Summary
D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS received FDA 510(k) clearance under submission number K112525, sponsored by Parexel International. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2011-09-29.
- Submission: K112525
- Applicant / Sponsor: Parexel International
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4260
- Decision date: 2011-09-29
Classification & Regulation
This clearance is catalogued under FDA product code DTM and 21 CFR 870.4260, within the Cardiovascular review panel as a Class II device.