FDA 510(k)

SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports

Número K: K190559 · 2020-05-22

Data da decisão2020-05-22

Código do produtoLJT

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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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Fonte oficial

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