Clearance Summary
4F-7F MEDI-DYNE TORQ FLOW XLB ANGIOGRAPHIC CATHETER received FDA 510(k) clearance under submission number K000825, sponsored by Medi-Dyne, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2000-09-21.
- Submission: K000825
- Applicant / Sponsor: Medi-Dyne, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1200
- Decision date: 2000-09-21
Classification & Regulation
This clearance is catalogued under FDA product code DQO and 21 CFR 870.1200, within the Cardiovascular review panel as a Class II device.