FDA 510(k)

RemunityPRO+ Pump for Remodulin® (treprostinil) Injection

Номер K: K253703 · 2026-07-24

Дата решения2026-07-24

Код продуктаFRN

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: FRN)

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Официальный источник

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