FDA PMA

Drug-eluting percutaneous transluminal coronary angioplasty catheter

Номер PMA: P250041 · 2026-09-18

ЗаявительMedAlliance, LLC

Дата решения2026-09-18

Номер PMAP250041

Код продуктаOOB

Класс устройстваКласс 3

Медицинская специализацияU

Консультативный комитетCV

Описание устройства

Drug-eluting percutaneous transluminal coronary angioplasty catheter is the device name listed in this FDA 510(k) record. The listed applicant is MedAlliance, LLC. It received FDA 510(k) clearance on 2026-09-18. The device is classified under product code OOB. It was reviewed by the CV advisory panel.

Часто задаваемые вопросы

What is the Drug-eluting percutaneous transluminal coronary angioplasty catheter?

Drug-eluting percutaneous transluminal coronary angioplasty catheter is a medical device that received FDA 510(k) clearance on 2026-09-18. The listed applicant is MedAlliance, LLC.

When did Drug-eluting percutaneous transluminal coronary angioplasty catheter receive FDA 510(k) clearance?

The clearance date for Drug-eluting percutaneous transluminal coronary angioplasty catheter can be found in the official FDA records.

Who is the listed applicant for Drug-eluting percutaneous transluminal coronary angioplasty catheter?

The FDA 510(k) record lists MedAlliance, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Drug-eluting percutaneous transluminal coronary angioplasty catheter?

The FDA product code for Drug-eluting percutaneous transluminal coronary angioplasty catheter is OOB.

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.

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

Официальный источник

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