Clearance Summary
COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67 received FDA 510(k) clearance under submission number K964821, sponsored by Ventrex, 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 1997-07-16.
- Submission: K964821
- Applicant / Sponsor: Ventrex, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2700
- Decision date: 1997-07-16
Classification & Regulation
This clearance is catalogued under FDA product code DQA and 21 CFR 870.2700, within the Cardiovascular review panel as a Class II device.