Clearance Summary
PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE received FDA 510(k) clearance under submission number K874405, sponsored by Pall Biomedical Products Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1987-12-30.
- Submission: K874405
- Applicant / Sponsor: Pall Biomedical Products Co.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4270
- Decision date: 1987-12-30
Classification & Regulation
This clearance is catalogued under FDA product code JOD and 21 CFR 870.4270, within the Cardiovascular review panel as a Class II device.