Clearance Summary
FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P) received FDA 510(k) clearance under submission number K963248, 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 1997-02-03.
- Submission: K963248
- Applicant / Sponsor: J-Lloyd Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1240
- Decision date: 1997-02-03
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.