Clearance Summary
EZ-INTRO PERCUTANEOUS CATHETER SHEATH, EZ-INTRO VESSEL DILATOR received FDA 510(k) clearance under submission number K983940, sponsored by Adam Spence Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1999-07-15.
- Submission: K983940
- Applicant / Sponsor: Adam Spence Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1340
- Decision date: 1999-07-15
Classification & Regulation
This clearance is catalogued under FDA product code DYB and 21 CFR 870.1340, within the Cardiovascular review panel as a Class II device.