FDA 510(k)

Turbo-Elite Laser Atherectomy Catheter

N.º K: K250385 · 2025-03-13

Fecha de decisión2025-03-13

Código de productoMCW

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Turbo-Elite Laser Atherectomy Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Spectranetics. It received FDA 510(k) clearance on 2025-03-13 under 510(k) number K250385. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Turbo-Elite Laser Atherectomy Catheter?

Turbo-Elite Laser Atherectomy Catheter is a medical device that received FDA 510(k) clearance on 2025-03-13. The listed applicant is Spectranetics. The 510(k) number is K250385.

When did Turbo-Elite Laser Atherectomy Catheter receive FDA 510(k) clearance?

Turbo-Elite Laser Atherectomy Catheter received FDA 510(k) clearance on 2025-03-13, under 510(k) number K250385.

Who is the listed applicant for Turbo-Elite Laser Atherectomy Catheter?

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

What is the FDA product code for Turbo-Elite Laser Atherectomy Catheter?

The FDA product code for Turbo-Elite Laser Atherectomy Catheter is MCW.

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: MCW)

K260244Auryon Atherectomy SystemEximo Medical K250723FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)Cardio Flow Inc.,K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc.K242947FreedomFlow™ Orbital Circumferential Atherectomy SystemCardio Flow Inc.,K241553Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingEximo Medical, Ltd.K233483FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)Cardio Flow Inc.,

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.