Clearance Summary
INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX received FDA 510(k) clearance under submission number K002847, sponsored by Maxxim Medical. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2001-05-31.
- Submission: K002847
- Applicant / Sponsor: Maxxim Medical
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1340
- Decision date: 2001-05-31
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.