FDA 510(k)

VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET

K-Number: K062414 · 2007-02-01

Decision Date2007-02-01

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET 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 2007-02-01 under 510(k) number K062414. 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 CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET?

VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET is a medical device that received FDA 510(k) clearance on 2007-02-01. The listed applicant is Rita Medical Systems, Inc.. The 510(k) number is K062414.

When did VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET receive FDA 510(k) clearance?

VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET received FDA 510(k) clearance on 2007-02-01, under 510(k) number K062414.

Who is the listed applicant for VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET?

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 CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET?

The FDA product code for VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET is LJT.

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Other records listing Rita Medical Systems, Inc. as applicant

K070101UNIBLATE ELECTROSURGICAL DEVICE K062579OMNIPICC P.I.K051102OMNIPICC PI K050176VORTEX EZ VASCULAR ACCESS PORT K032149RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR K031926RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR AND ACCESSORIES (E.G., RITA THERMO PAD AND CABLE ADAPTER)

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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.