FDA 510(k)

TRIUMPH VTX WITH LIFEVALVE CATHETER

K-Number: K032557 · 2003-09-09

Decision Date2003-09-09

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

TRIUMPH VTX WITH LIFEVALVE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Horizon Medical Products, Inc.. It received FDA 510(k) clearance on 2003-09-09 under 510(k) number K032557. The device is classified under product code LJT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIUMPH VTX WITH LIFEVALVE CATHETER?

TRIUMPH VTX WITH LIFEVALVE CATHETER is a medical device that received FDA 510(k) clearance on 2003-09-09. The listed applicant is Horizon Medical Products, Inc.. The 510(k) number is K032557.

When did TRIUMPH VTX WITH LIFEVALVE CATHETER receive FDA 510(k) clearance?

TRIUMPH VTX WITH LIFEVALVE CATHETER received FDA 510(k) clearance on 2003-09-09, under 510(k) number K032557.

Who is the listed applicant for TRIUMPH VTX WITH LIFEVALVE CATHETER?

The FDA 510(k) record lists Horizon Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRIUMPH VTX WITH LIFEVALVE CATHETER?

The FDA product code for TRIUMPH VTX WITH LIFEVALVE CATHETER is LJT.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Horizon Medical Products, Inc. as applicant

K033473MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT K032754VORTEX MP K031718LIFEVALVE CENTRAL VENOUS CATHTER K022905LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER K013871LIFEGUARD SAFETY INFUSION SET K011916SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES

View all 16 devices →

Related Devices (Code: LJT)

K260916FLEXI-PORT™ Power Injectable Implantable PortPortal Access, Inc.K252478Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable PortBard Access Systems, Inc.K251253PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable PortBard Access Systems, Inc.K242328PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable PortsBard Access Systems, Inc.K232737PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG Enabled Implantable Port; PowerPort™ isp M.R.I.™ ECG Enabled Implantable Port; PowerPort™ Slim ECG Enabled Implantable PortBard Peripheral Vascular, Inc.K190559SmartPort+ Implantable Ports, SmartPort Plastic Implantable PortsAngioDynamics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.