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FDA 510(k)

Remunity Pump for Remodulin (treprostinil) Injection

K-Number: K202690 · 2020-12-30

ApplicantDeka Research and Development
Decision Date2020-12-30
Product CodeQJY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Remunity Pump for Remodulin (treprostinil) Injection is the device name listed in this FDA 510(k) record. The listed applicant is Deka Research and Development. It received FDA 510(k) clearance on 2020-12-30 under 510(k) number K202690. 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 Remunity Pump for Remodulin (treprostinil) Injection?

Remunity Pump for Remodulin (treprostinil) Injection is a medical device that received FDA 510(k) clearance on 2020-12-30. The listed applicant is Deka Research and Development. The 510(k) number is K202690.

When did Remunity Pump for Remodulin (treprostinil) Injection receive FDA 510(k) clearance?

Remunity Pump for Remodulin (treprostinil) Injection received FDA 510(k) clearance on 2020-12-30, under 510(k) number K202690.

Who is the listed applicant for Remunity Pump for Remodulin (treprostinil) Injection?

The FDA 510(k) record lists Deka Research and Development as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Remunity Pump for Remodulin (treprostinil) Injection?

The FDA product code for Remunity Pump for Remodulin (treprostinil) Injection is QJY.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06853990Innovative Automated Insulin Delivery System for Type 2 DiabetesCOMPLETED

Other records listing Deka Research and Development as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261672twiist Automated Insulin Delivery (AID) SystemK261530iiSure Infusion SetK243841Sparta Infusion Set for InsulinK241736Remunity 2.0 Pump for Remodulin (treprostinil) InjectionK242693DEKA Infusion System, DEKA Administration SetK240920HemoCare Bicarbonate Concentrate Set (BCS)

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Related Devices (Code: QJY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243354Remunity SystemDeka Research & Development Corp.K240256Remunity SystemDeka Research and DevelopmentK191313Unity Subcutaneous Infusion System for RemodulinDEKA Research & 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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