FDA 510(k)

MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT

K-Number: K033473 · 2003-11-18

Decision Date2003-11-18

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT 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 2003-11-18 under 510(k) number K033473. 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 MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT?

MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT is a medical device that received FDA 510(k) clearance on 2003-11-18. The listed applicant is Horizon Medical Products, Inc.. The 510(k) number is K033473.

When did MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT receive FDA 510(k) clearance?

MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT received FDA 510(k) clearance on 2003-11-18, under 510(k) number K033473.

Who is the listed applicant for MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT?

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 MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT?

The FDA product code for MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT is LJT.

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Other records listing Horizon Medical Products, Inc. as applicant

K032754VORTEX MP K032557TRIUMPH VTX WITH LIFEVALVE CATHETER 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

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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.