Clearance Summary
LIISA LEVER INTEGRATED INTERVENTIONAL SYSTEM ADAPTER, MODEL VSL-109 received FDA 510(k) clearance under submission number K073260, sponsored by Device Partners International. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2008-03-13.
- Submission: K073260
- Applicant / Sponsor: Device Partners International
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4290
- Decision date: 2008-03-13
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.