Clearance Summary
TUBING PACK, EXTRACORPOREAL, H-3000 received FDA 510(k) clearance under submission number K770720, sponsored by William Harvey Life Products Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1977-08-04.
- Submission: K770720
- Applicant / Sponsor: William Harvey Life Products Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4100
- Decision date: 1977-08-04
Classification & Regulation
This clearance is catalogued under FDA product code BYS and 21 CFR 870.4100, within the Cardiovascular review panel as a Class II device.