FDA 510(k)

BardPort®, SlimPort®, and X-Port® Implanted Ports

K-Number: K153359 · 2016-05-20

Decision Date2016-05-20

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

BardPort®, SlimPort®, and X-Port® Implanted Ports is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2016-05-20 under 510(k) number K153359. 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 BardPort®, SlimPort®, and X-Port® Implanted Ports?

BardPort®, SlimPort®, and X-Port® Implanted Ports is a medical device that received FDA 510(k) clearance on 2016-05-20. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K153359.

When did BardPort®, SlimPort®, and X-Port® Implanted Ports receive FDA 510(k) clearance?

BardPort®, SlimPort®, and X-Port® Implanted Ports received FDA 510(k) clearance on 2016-05-20, under 510(k) number K153359.

Who is the listed applicant for BardPort®, SlimPort®, and X-Port® Implanted Ports?

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

What is the FDA product code for BardPort®, SlimPort®, and X-Port® Implanted Ports?

The FDA product code for BardPort®, SlimPort®, and X-Port® Implanted Ports 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

View on FDA Database →

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