Clearance Summary
SHEATH/DILATORS received FDA 510(k) clearance under submission number K872724, sponsored by Med-West, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1987-09-15.
- Submission: K872724
- Applicant / Sponsor: Med-West, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1310
- Decision date: 1987-09-15
Classification & Regulation
This clearance is catalogued under FDA product code DRE and 21 CFR 870.1310, within the Cardiovascular review panel as a Class II device.