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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 a medical device manufactured by AngioDynamics, Inc.. It received FDA 510(k) clearance on 2020-05-22 under approval 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. It is manufactured by AngioDynamics, Inc.. The 510(k) number is K190559.

When was SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports approved by the FDA?

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

What company makes SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports?

SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports is manufactured by AngioDynamics, Inc..

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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Official Source

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