FDA 510(k)

DIGNITY POWER INJECTABLE TITANIUM PORT

K-Number: K120281 · 2012-09-17

Decision Date2012-09-17

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

DIGNITY POWER INJECTABLE TITANIUM PORT is the device name listed in this FDA 510(k) record. The listed applicant is Medical Components, Inc.. It received FDA 510(k) clearance on 2012-09-17 under 510(k) number K120281. 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 DIGNITY POWER INJECTABLE TITANIUM PORT?

DIGNITY POWER INJECTABLE TITANIUM PORT is a medical device that received FDA 510(k) clearance on 2012-09-17. The listed applicant is Medical Components, Inc.. The 510(k) number is K120281.

When did DIGNITY POWER INJECTABLE TITANIUM PORT receive FDA 510(k) clearance?

DIGNITY POWER INJECTABLE TITANIUM PORT received FDA 510(k) clearance on 2012-09-17, under 510(k) number K120281.

Who is the listed applicant for DIGNITY POWER INJECTABLE TITANIUM PORT?

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

What is the FDA product code for DIGNITY POWER INJECTABLE TITANIUM PORT?

The FDA product code for DIGNITY POWER INJECTABLE TITANIUM PORT is LJT.

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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.