FDA 510(k)

DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System

Número K: K171217 · 2017-05-26

Data da decisão2017-05-26

Código do produtoDXT

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System is the device name listed in this FDA 510(k) record. The listed applicant is Osprey Medical, Inc.. It received FDA 510(k) clearance on 2017-05-26 under 510(k) number K171217. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System?

DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System is a medical device that received FDA 510(k) clearance on 2017-05-26. The listed applicant is Osprey Medical, Inc.. The 510(k) number is K171217.

When did DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System receive FDA 510(k) clearance?

DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System received FDA 510(k) clearance on 2017-05-26, under 510(k) number K171217.

Who is the listed applicant for DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System?

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

What is the FDA product code for DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System?

The FDA product code for DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System is DXT.

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 Osprey Medical, Inc. como candidato(a)

K190102DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction System K183267DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction System, DyeTect™ Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert™ PLUS EZ Contrast Reduction System K181936DyeVert PLUS EZ Contrast Reduction System K171698Smart Syringe K163054DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System K161505DyeVert NG Contrast Modulation System

Ver todos os 8 dispositivos →

Dispositivos Relacionados (Código: DXT)

K252652Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable SyrFortis Biosolutions Company Limited K252638VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804)Acist Medical Systems, Inc.K252653Sistema de Diagnóstico ACIST Pro (019304); Unidade de Processamento Montada na Cama; Módulo AngioTouch; Carrinho ACIST Pro; Cabo de Transdutor Único; Cabo de Transdutor TripleAcist Medical Systems, Inc.K253048High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer TubeShenzhen Maiwei Biotech Co., Ltd.K251788Extension tubeZhuhai DR Medical Instruments Co., Ltd.K252891MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)Bayer Medical Care, 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.