Clearance Summary
PINNACLE R/O OR REDIFOCUS INTRODUCER R/O (COMPRISED OF A SHEATH & DILATOR) received FDA 510(k) clearance under submission number K984260, sponsored by Terumo Medical Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1999-01-26.
- Submission: K984260
- Applicant / Sponsor: Terumo Medical Corp.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1340
- Decision date: 1999-01-26
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.