Clearance Summary
FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATED received FDA 510(k) clearance under submission number K940547, sponsored by J-Lloyd Medical, 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 1994-08-11.
- Submission: K940547
- Applicant / Sponsor: J-Lloyd Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1240
- Decision date: 1994-08-11
Classification & Regulation
This clearance is catalogued under FDA product code DYG and 21 CFR 870.1240, within the Cardiovascular review panel as a Class II device.