Clearance Summary
MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER received FDA 510(k) clearance under submission number K982883, sponsored by Medtronics Interventional Vascular. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1998-09-04.
- Submission: K982883
- Applicant / Sponsor: Medtronics Interventional Vascular
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 1998-09-04
Classification & Regulation
This clearance is catalogued under FDA product code DQY and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.