Clearance Summary
GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE received FDA 510(k) clearance under submission number K122301, sponsored by Vascular Solutions Zerusa , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2012-09-07.
- Submission: K122301
- Applicant / Sponsor: Vascular Solutions Zerusa , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4290
- Decision date: 2012-09-07
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.