Clearance Summary
EMCEE INTRODUCER SHEATH, DILATOR, OBTURATOR, INTRODUCER SET received FDA 510(k) clearance under submission number K980504, sponsored by Schneider/Namic. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1998-08-07.
- Submission: K980504
- Applicant / Sponsor: Schneider/Namic
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1340
- Decision date: 1998-08-07
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.