Clearance Summary
VACUETTE SAFELINK Holder with male luer lock received FDA 510(k) clearance under submission number K180545, sponsored by Greiner Bio-One Na, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2018-05-21.
- Submission: K180545
- Applicant / Sponsor: Greiner Bio-One Na, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 2018-05-21
Classification & Regulation
This clearance is catalogued under FDA product code FMI and 21 CFR 880.5570, within the General Hospital review panel as a Class II device.