Clearance Summary
WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD received FDA 510(k) clearance under submission number K935403, 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 1994-05-12.
- Submission: K935403
- Applicant / Sponsor: J-Lloyd Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1200
- Decision date: 1994-05-12
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.