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)

Peel-Away Introducer Sheath

N.º K: K254236 · 2026-02-09

SolicitanteVascuTech Medical, LLC
Fecha de decisión2026-02-09
Código de productoDYB
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

Peel-Away Introducer Sheath is the device name listed in this FDA 510(k) record. The listed applicant is VascuTech Medical, LLC. It received FDA 510(k) clearance on 2026-02-09 under 510(k) number K254236. 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 Peel-Away Introducer Sheath?

Peel-Away Introducer Sheath is a medical device that received FDA 510(k) clearance on 2026-02-09. The listed applicant is VascuTech Medical, LLC. The 510(k) number is K254236.

When did Peel-Away Introducer Sheath receive FDA 510(k) clearance?

Peel-Away Introducer Sheath received FDA 510(k) clearance on 2026-02-09, under 510(k) number K254236.

Who is the listed applicant for Peel-Away Introducer Sheath?

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

What is the FDA product code for Peel-Away Introducer Sheath?

The FDA product code for Peel-Away Introducer Sheath 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.

↑