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FDA 510(k)

Dignity Dual Port

K-Number: K153238 · 2016-03-15

ApplicantMedcomp ( Medical Components)
Decision Date2016-03-15
Product CodeLJT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Dignity Dual Port is the device name listed in this FDA 510(k) record. The listed applicant is Medcomp ( Medical Components). It received FDA 510(k) clearance on 2016-03-15 under 510(k) number K153238. 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 Dual Port?

Dignity Dual Port is a medical device that received FDA 510(k) clearance on 2016-03-15. The listed applicant is Medcomp ( Medical Components). The 510(k) number is K153238.

When did Dignity Dual Port receive FDA 510(k) clearance?

Dignity Dual Port received FDA 510(k) clearance on 2016-03-15, under 510(k) number K153238.

Who is the listed applicant for Dignity Dual Port?

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

What is the FDA product code for Dignity Dual Port?

The FDA product code for Dignity Dual Port is LJT.

Other records listing Medcomp ( Medical Components) 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.

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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

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

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