Clearance Summary
TRIUMPH VTX WITH LIFEVALVE CATHETER received FDA 510(k) clearance under submission number K032557, sponsored by Horizon Medical Products, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2003-09-09.
- Submission: K032557
- Applicant / Sponsor: Horizon Medical Products, Inc.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5965
- Decision date: 2003-09-09
Classification & Regulation
This clearance is catalogued under FDA product code LJT and 21 CFR 880.5965, within the General Hospital review panel as a Class II device.