FDA 510(k)

RemunityPRO+ Pump for Remodulin® (treprostinil) Injection

Número K: K253703 · 2026-07-24

Data da decisão2026-07-24

Código do produtoFRN

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

RemunityPRO+ Pump for Remodulin® (treprostinil) Injection is the device name listed in this FDA 510(k) record. The listed applicant is Deka R&D Corp. It received FDA 510(k) clearance on 2026-07-24 under 510(k) number K253703. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the RemunityPRO+ Pump for Remodulin® (treprostinil) Injection?

RemunityPRO+ Pump for Remodulin® (treprostinil) Injection is a medical device that received FDA 510(k) clearance on 2026-07-24. The listed applicant is Deka R&D Corp. The 510(k) number is K253703.

When did RemunityPRO+ Pump for Remodulin® (treprostinil) Injection receive FDA 510(k) clearance?

RemunityPRO+ Pump for Remodulin® (treprostinil) Injection received FDA 510(k) clearance on 2026-07-24, under 510(k) number K253703.

Who is the listed applicant for RemunityPRO+ Pump for Remodulin® (treprostinil) Injection?

The FDA 510(k) record lists Deka R&D Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RemunityPRO+ Pump for Remodulin® (treprostinil) Injection?

The FDA product code for RemunityPRO+ Pump for Remodulin® (treprostinil) Injection is FRN.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos Relacionados (Código: FRN)

K252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc.K251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare Corporation K242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed Corporation K243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc.K242115Plum Duo™ Precision IV PumpIcu Medical, Inc.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.