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FDA 510(k)

VORTEX ACCESS SYSTEM

K-Number: K010189 · 2001-02-12

ApplicantHorizon Medical Products, Inc.
Decision Date2001-02-12
Product CodeLJT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VORTEX ACCESS SYSTEM 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 2001-02-12 under 510(k) number K010189. 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 ACCESS SYSTEM?

VORTEX ACCESS SYSTEM is a medical device that received FDA 510(k) clearance on 2001-02-12. The listed applicant is Horizon Medical Products, Inc.. The 510(k) number is K010189.

When did VORTEX ACCESS SYSTEM receive FDA 510(k) clearance?

VORTEX ACCESS SYSTEM received FDA 510(k) clearance on 2001-02-12, under 510(k) number K010189.

Who is the listed applicant for VORTEX ACCESS SYSTEM?

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 ACCESS SYSTEM?

The FDA product code for VORTEX ACCESS SYSTEM 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 PORTK032754VORTEX MPK032557TRIUMPH VTX WITH LIFEVALVE CATHETERK031718LIFEVALVE CENTRAL VENOUS CATHTERK022905LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETERK013871LIFEGUARD SAFETY INFUSION SET

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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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