Clearance Summary
ARGYLE GRIFFITH TDMAC HEPARINIZED VENO-VENOUS SHUN received FDA 510(k) clearance under submission number K850917, sponsored by Sherwood Medical Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1985-05-21.
- Submission: K850917
- Applicant / Sponsor: Sherwood Medical Co.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4210
- Decision date: 1985-05-21
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.