Clearance Summary
HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER received FDA 510(k) clearance under submission number K971504, 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 1998-04-20.
- Submission: K971504
- Applicant / Sponsor: J-Lloyd Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1220
- Decision date: 1998-04-20
Classification & Regulation
This clearance is catalogued under FDA product code DRF and 21 CFR 870.1220, within the Cardiovascular review panel as a Class II device.