Clearance Summary
STOCKERT A242 AND A252 SERIES ARTERIAL FEMORAL CANNULAE received FDA 510(k) clearance under submission number K001961, sponsored by Stoeckert Instrumente. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2001-01-25.
- Submission: K001961
- Applicant / Sponsor: Stoeckert Instrumente
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4210
- Decision date: 2001-01-25
Classification & Regulation
This clearance is catalogued under FDA product code DWF and 21 CFR 870.4210, within the Cardiovascular review panel as a Class II device.