FDA 510(k)

PreludeSYNC™ Radial Compression Device

Número K: K262086 · 2026-07-22

Data da decisão2026-07-22

Código do produtoDXC

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

PreludeSYNC™ Radial Compression Device is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2026-07-22 under 510(k) number K262086. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PreludeSYNC™ Radial Compression Device?

PreludeSYNC™ Radial Compression Device is a medical device that received FDA 510(k) clearance on 2026-07-22. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K262086.

When did PreludeSYNC™ Radial Compression Device receive FDA 510(k) clearance?

PreludeSYNC™ Radial Compression Device received FDA 510(k) clearance on 2026-07-22, under 510(k) number K262086.

Who is the listed applicant for PreludeSYNC™ Radial Compression Device?

The FDA 510(k) record lists Merit Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PreludeSYNC™ Radial Compression Device?

The FDA product code for PreludeSYNC™ Radial Compression Device is DXC.

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

Outros registros que listam Merit Medical Systems, Inc. como candidato(a)

K261310FlexTract Deflectable-Rotational Dilator Sheath Set K254073StatSeal Disc K251802STAR RF Ablation System K252892SCOUT MD Surgical Guidance System K250853Merit Syringe K251265Resilience Fully Covered Esophageal Stent System

Ver todos os 66 dispositivos →

Dispositivos Relacionados (Código: DXC)

K260105Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsEdwards Lifesciences K252772Arc Ajustável do Braço Radial de CompressãoTz Medical, Inc.K254060Life Saving TourniquetTW Medical K243627Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)Arc Trauma, LLC K253070Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)Medline Industries, LP K232577Radial Compression DeviceNingbo Dizegens Medical Science Co.,Ltd

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.