FDA 510(k)

SOUNDSTAR™ CRYSTAL Ultrasound Catheter

Número K: K240050 · 2024-06-12

Data da decisão2024-06-12

Código do produtoOBJ

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

SOUNDSTAR™ CRYSTAL Ultrasound Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Biosense Webster, Inc.. It received FDA 510(k) clearance on 2024-06-12 under 510(k) number K240050. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SOUNDSTAR™ CRYSTAL Ultrasound Catheter?

SOUNDSTAR™ CRYSTAL Ultrasound Catheter is a medical device that received FDA 510(k) clearance on 2024-06-12. The listed applicant is Biosense Webster, Inc.. The 510(k) number is K240050.

When did SOUNDSTAR™ CRYSTAL Ultrasound Catheter receive FDA 510(k) clearance?

SOUNDSTAR™ CRYSTAL Ultrasound Catheter received FDA 510(k) clearance on 2024-06-12, under 510(k) number K240050.

Who is the listed applicant for SOUNDSTAR™ CRYSTAL Ultrasound Catheter?

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

What is the FDA product code for SOUNDSTAR™ CRYSTAL Ultrasound Catheter?

The FDA product code for SOUNDSTAR™ CRYSTAL Ultrasound Catheter is OBJ.

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 Biosense Webster, Inc. como candidato(a)

K252972CARTO™ 3 EP Navigation System V8.4 K254085Sistema de Navegação CARTO™ 3 EP V9.0 com PIU Plus K252302CARTO™ 3 EP Navigation System V8.1 K241540NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter K231207CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)K231312PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID

Ver todos os 25 dispositivos →

Dispositivos Relacionados (Código: OBJ)

K261696ACUNAV Luxera 4D ICE CatheterSiemens Medical Solutions USA, Inc.K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited K252945Novasight Hybrid SystemConavi Medical, Inc.K260816OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090)Boston Scientific K253399Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS CatheterVolcano Corporation (Dba Philips Image Guided Therapy Device K250955XC11 ICE System, USAYorlabs, 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.