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FDA 510(k)

VORTEX MP

K-Number: K032754 · 2003-09-12

ApplicantHorizon Medical Products, Inc.
Decision Date2003-09-12
Product CodeLJT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VORTEX MP 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 2003-09-12 under 510(k) number K032754. 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 VORTEX MP?

VORTEX MP is a medical device that received FDA 510(k) clearance on 2003-09-12. The listed applicant is Horizon Medical Products, Inc.. The 510(k) number is K032754.

When did VORTEX MP receive FDA 510(k) clearance?

VORTEX MP received FDA 510(k) clearance on 2003-09-12, under 510(k) number K032754.

Who is the listed applicant for VORTEX MP?

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 VORTEX MP?

The FDA product code for VORTEX MP is LJT.

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Other records listing Horizon Medical Products, Inc. as applicant

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.

K033473MODIFICATION TO VORTEX MP VASCULAR ACCESS PORTK032557TRIUMPH VTX WITH LIFEVALVE CATHETERK031718LIFEVALVE CENTRAL VENOUS CATHTERK022905LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETERK013871LIFEGUARD SAFETY INFUSION SETK011916SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES

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Related Devices (Code: LJT)

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.

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.

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