FDA 510(k)

VORTEX EZ VASCULAR ACCESS PORT

K-Number: K050176 · 2005-02-25

Decision Date2005-02-25

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

VORTEX EZ VASCULAR ACCESS PORT is the device name listed in this FDA 510(k) record. The listed applicant is Rita Medical Systems, Inc.. It received FDA 510(k) clearance on 2005-02-25 under 510(k) number K050176. 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 EZ VASCULAR ACCESS PORT?

VORTEX EZ VASCULAR ACCESS PORT is a medical device that received FDA 510(k) clearance on 2005-02-25. The listed applicant is Rita Medical Systems, Inc.. The 510(k) number is K050176.

When did VORTEX EZ VASCULAR ACCESS PORT receive FDA 510(k) clearance?

VORTEX EZ VASCULAR ACCESS PORT received FDA 510(k) clearance on 2005-02-25, under 510(k) number K050176.

Who is the listed applicant for VORTEX EZ VASCULAR ACCESS PORT?

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

What is the FDA product code for VORTEX EZ VASCULAR ACCESS PORT?

The FDA product code for VORTEX EZ VASCULAR ACCESS PORT is LJT.

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Other records listing Rita Medical Systems, Inc. as applicant

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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

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