FDA 510(k)

SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports

K-Number: K190559 · 2020-05-22

Decision Date2020-05-22

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports is the device name listed in this FDA 510(k) record. The listed applicant is AngioDynamics, Inc.. It received FDA 510(k) clearance on 2020-05-22 under 510(k) number K190559. 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 SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports?

SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports is a medical device that received FDA 510(k) clearance on 2020-05-22. The listed applicant is AngioDynamics, Inc.. The 510(k) number is K190559.

When did SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports receive FDA 510(k) clearance?

SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports received FDA 510(k) clearance on 2020-05-22, under 510(k) number K190559.

Who is the listed applicant for SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports?

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

What is the FDA product code for SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports?

The FDA product code for SmartPort+ Implantable Ports, SmartPort Plastic Implantable 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.K181446Bard Power-Injectable Implantable Ports (PowerPorts®)C.R. Bard, 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.