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FDA 510(k)

Unity Subcutaneous Infusion System for Remodulin

K-Number: K191313 · 2020-02-21

ApplicantDEKA Research & Development
Decision Date2020-02-21
Product CodeQJY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Unity Subcutaneous Infusion System for Remodulin is a medical device manufactured by DEKA Research & Development. It received FDA 510(k) clearance on 2020-02-21 under approval number K191313. The device is classified under product code QJY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Unity Subcutaneous Infusion System for Remodulin?

Unity Subcutaneous Infusion System for Remodulin is a medical device that received FDA 510(k) clearance on 2020-02-21. It is manufactured by DEKA Research & Development. The 510(k) number is K191313.

When was Unity Subcutaneous Infusion System for Remodulin approved by the FDA?

Unity Subcutaneous Infusion System for Remodulin received FDA 510(k) clearance on 2020-02-21, under approval number K191313.

What company makes Unity Subcutaneous Infusion System for Remodulin?

Unity Subcutaneous Infusion System for Remodulin is manufactured by DEKA Research & Development.

What is the FDA product code for Unity Subcutaneous Infusion System for Remodulin?

The FDA product code for Unity Subcutaneous Infusion System for Remodulin is QJY.

Related Clinical Trials

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Other Devices by DEKA Research & Development

K153760Volumetric Infusion Controller K190182Unity Subcutaneous Delivery System for Remodulin

Related Devices (Code: QJY)

K202690Remunity Pump for Remodulin (treprostinil) InjectionDeka Research and Development K243354Remunity SystemDeka Research & Development Corp. K240256Remunity SystemDeka Research and Development

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.

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