Clearance Summary
EASYPASS US Y-CONNECTOR HEMOSTATIC VALVE received FDA 510(k) clearance under submission number K042060, sponsored by Millimed A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2004-10-06.
- Submission: K042060
- Applicant / Sponsor: Millimed A/S
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4290
- Decision date: 2004-10-06
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.