Clearance Summary
GUARDIAN II NC HEMOSTASIS VALVE received FDA 510(k) clearance under submission number K101113, sponsored by Zerusa Limited. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2010-05-21.
- Submission: K101113
- Applicant / Sponsor: Zerusa Limited
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4290
- Decision date: 2010-05-21
Classification & Regulation
This clearance is catalogued under FDA product code DTL and 21 CFR 870.4290, within the Cardiovascular review panel as a Class II device.