Aviso: Este sitio agrega datos públicos oficiales de la FDA, ClinicalTrials.gov, PubMed y SEC EDGAR solo como referencia general. No constituye asesoramiento médico, diagnóstico, recomendaciones de tratamiento ni asesoramiento de inversión.

FDA 510(k)

RadialSeal Introducer Kit

N.º K: K181855 · 2018-07-26

SolicitanteGreat Batch Medical
Fecha de decisión2018-07-26
Código de productoDYB
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

RadialSeal Introducer Kit is the device name listed in this FDA 510(k) record. The listed applicant is Great Batch Medical. It received FDA 510(k) clearance on 2018-07-26 under 510(k) number K181855. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the RadialSeal Introducer Kit?

RadialSeal Introducer Kit is a medical device that received FDA 510(k) clearance on 2018-07-26. The listed applicant is Great Batch Medical. The 510(k) number is K181855.

When did RadialSeal Introducer Kit receive FDA 510(k) clearance?

RadialSeal Introducer Kit received FDA 510(k) clearance on 2018-07-26, under 510(k) number K181855.

Who is the listed applicant for RadialSeal Introducer Kit?

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

What is the FDA product code for RadialSeal Introducer Kit?

The FDA product code for RadialSeal Introducer Kit is DYB.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos relacionados (Código: DYB)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

↑