Clearance Summary
PORTA-FIB LPD received FDA 510(k) clearance under submission number K801544, sponsored by Narco Bio-Systems. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1980-07-14.
- Submission: K801544
- Applicant / Sponsor: Narco Bio-Systems
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5300
- Decision date: 1980-07-14
Classification & Regulation
This clearance is catalogued under FDA product code LDD and 21 CFR 870.5300, within the Cardiovascular review panel as a Class II device.