Clearance Summary
GUIDING CATHETERS 9F JL4 received FDA 510(k) clearance under submission number K871021, sponsored by Devices For Vascular Intervention, 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 1987-06-16.
- Submission: K871021
- Applicant / Sponsor: Devices For Vascular Intervention, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1200
- Decision date: 1987-06-16
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.