FDA 510(k)

Viatrac 14 Plus Peripheral Dilatation Catheter

N.º K: K221057 · 2022-05-05

Fecha de decisión2022-05-05

Código de productoLIT

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Viatrac 14 Plus Peripheral Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Vascular. It received FDA 510(k) clearance on 2022-05-05 under 510(k) number K221057. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Viatrac 14 Plus Peripheral Dilatation Catheter?

Viatrac 14 Plus Peripheral Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2022-05-05. The listed applicant is Abbott Vascular. The 510(k) number is K221057.

When did Viatrac 14 Plus Peripheral Dilatation Catheter receive FDA 510(k) clearance?

Viatrac 14 Plus Peripheral Dilatation Catheter received FDA 510(k) clearance on 2022-05-05, under 510(k) number K221057.

Who is the listed applicant for Viatrac 14 Plus Peripheral Dilatation Catheter?

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

What is the FDA product code for Viatrac 14 Plus Peripheral Dilatation Catheter?

The FDA product code for Viatrac 14 Plus Peripheral Dilatation Catheter is LIT.

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 Abbott Vascular como solicitante

Ver todos los 11 dispositivos →

Dispositivos relacionados (Código: LIT)

K260416ZYLOX Hippo PTA Balloon Dilatation CatheterZylox Medtech Co., Ltd.K254212NC PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.K260304WAVE PTA Balloon CatheterWAVE Medical AG K252512Catheter Armada™ 14 NC PTAABBOTT MEDICAL K251915Cáteter Amethyst HP PTA OTW 0.035Natec Medical , Ltd.K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) CatheterBiotronik, 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.