FDA 510(k)

M-Y Sheath

N.º K: K190369 · 2019-04-17

SolicitanteRam Medical Innovations, Inc.

Fecha de decisión2019-04-17

Código de productoDYB

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

M-Y Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Ram Medical Innovations, Inc.. It received FDA 510(k) clearance on 2019-04-17 under 510(k) number K190369. 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 M-Y Sheath?

M-Y Sheath is a medical device that received FDA 510(k) clearance on 2019-04-17. The listed applicant is Ram Medical Innovations, Inc.. The 510(k) number is K190369.

When did M-Y Sheath receive FDA 510(k) clearance?

M-Y Sheath received FDA 510(k) clearance on 2019-04-17, under 510(k) number K190369.

Who is the listed applicant for M-Y Sheath?

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

What is the FDA product code for M-Y Sheath?

The FDA product code for M-Y 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_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

Dispositivos relacionados (Código: DYB)

K253526NAMIC Dilator and SheathMedline Industries, LP K261529Micropuncture 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, LLC K261242SimplGuidePendracare K261950Health Line Tearaway IntroducerHealth Line International Corporation K261492FieldFlex Steerable SheathCenterPoint Systems, LLC K260606Echo 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.