FDA 510(k)

Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter

Número K: K190132 · 2019-07-30

Data da decisão2019-07-30

Código do produtoDRF

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic. It received FDA 510(k) clearance on 2019-07-30 under 510(k) number K190132. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter?

Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter is a medical device that received FDA 510(k) clearance on 2019-07-30. The listed applicant is Medtronic. The 510(k) number is K190132.

When did Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter receive FDA 510(k) clearance?

Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter received FDA 510(k) clearance on 2019-07-30, under 510(k) number K190132.

Who is the listed applicant for Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter?

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

What is the FDA product code for Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter?

The FDA product code for Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter is DRF.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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

Outros registros que listam Medtronic como candidato(a)

K253530Trexon™ Monofilament Synthetic Absorbable Suture K251744Affinity Pixie™ Filtro Arterial com Superfície Biológica Balance™; Affinity® Filtro Arterial de Sangue Pediátrico K233433Sphere-9Dx Diagnostic Catheter (AFR-00009)K240190MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated K223494CD Horizon Spinal System K223178SelectSite C304 Deflectable Catheter System, C315 Delivery System

Ver todos os 26 dispositivos →

Dispositivos Relacionados (Código: DRF)

K252794Vision-MR™ Diagnostic CatheterImricor Medical Systems, Inc.K250590MAGiC Sweep™ EP Mapping CatheterStereotaxis, Inc.K250310VIKING™ Fixed Curve Diagnostic CatheterBoston Scientific Corporation K240366EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic CatheterBoston Scientific Corporation K233900Nordica PV Cryo Mapping CatheterSynaptic Medical Corporation K233397Cosine-10TM Diagnostic CatheterMedtronic, Inc.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.