Clearance Summary
BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL RF-320J received FDA 510(k) clearance under submission number K052578, sponsored by Bard Peripheral Vascular, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2005-11-25.
- Submission: K052578
- Applicant / Sponsor: Bard Peripheral Vascular, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3375
- Decision date: 2005-11-25
Classification & Regulation
This clearance is catalogued under FDA product code DTK and 21 CFR 870.3375, within the Cardiovascular review panel as a Class II device.