FDA 510(k)

Edwards Balloon Catheter

N.º K: K153069 · 2016-01-07

Fecha de decisión2016-01-07

Código de productoOMZ

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Edwards Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences. It received FDA 510(k) clearance on 2016-01-07 under 510(k) number K153069. The device is classified under product code OMZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Edwards Balloon Catheter?

Edwards Balloon Catheter is a medical device that received FDA 510(k) clearance on 2016-01-07. The listed applicant is Edwards Lifesciences. The 510(k) number is K153069.

When did Edwards Balloon Catheter receive FDA 510(k) clearance?

Edwards Balloon Catheter received FDA 510(k) clearance on 2016-01-07, under 510(k) number K153069.

Who is the listed applicant for Edwards Balloon Catheter?

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

What is the FDA product code for Edwards Balloon Catheter?

The FDA product code for Edwards Balloon Catheter is OMZ.

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

Otros registros que enlistan a Edwards Lifesciences como solicitante

K254232ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150)K260105Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts K254279Edwards eSheath+ introducer set K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)K253034HemoSphere Stream Module K252364Edwards eSheath Optima introducer set

Ver todos los 17 dispositivos →

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.