FDA 510(k)

Parietene™ Flat Sheet Mesh

Номер K: K253125 · 2025-10-24

ЗаявительMedtronic - Sofradim Production

Дата решения2025-10-24

Код продуктаFTL

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

Parietene™ Flat Sheet Mesh is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic - Sofradim Production. It received FDA 510(k) clearance on 2025-10-24 under 510(k) number K253125. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Parietene™ Flat Sheet Mesh?

Parietene™ Flat Sheet Mesh is a medical device that received FDA 510(k) clearance on 2025-10-24. The listed applicant is Medtronic - Sofradim Production. The 510(k) number is K253125.

When did Parietene™ Flat Sheet Mesh receive FDA 510(k) clearance?

Parietene™ Flat Sheet Mesh received FDA 510(k) clearance on 2025-10-24, under 510(k) number K253125.

Who is the listed applicant for Parietene™ Flat Sheet Mesh?

The FDA 510(k) record lists Medtronic - Sofradim Production as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Parietene™ Flat Sheet Mesh?

The FDA product code for Parietene™ Flat Sheet Mesh is FTL.

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

Связанные устройства (Код: FTL)

K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim Production K251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc.K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc.K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim Production K250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedDavol, Inc.K243315ProGrip™ Self-Gripping Polypropylene MeshSofradim Production

Официальный источник

Посмотреть в базе данных FDA →

Данные получены из открытого API FDA. Для получения наиболее актуальной и авторитетной информации всегда обращайтесь к официальным записям.