FDA 510(k)

Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable

Número K: K183649 · 2019-06-07

Data da decisão2019-06-07

Código do produtoDRF

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable is the device name listed in this FDA 510(k) record. The listed applicant is Baylis Medical Company, Inc.. It received FDA 510(k) clearance on 2019-06-07 under 510(k) number K183649. 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 Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable?

Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable is a medical device that received FDA 510(k) clearance on 2019-06-07. The listed applicant is Baylis Medical Company, Inc.. The 510(k) number is K183649.

When did Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable receive FDA 510(k) clearance?

Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable received FDA 510(k) clearance on 2019-06-07, under 510(k) number K183649.

Who is the listed applicant for Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable?

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

What is the FDA product code for Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable?

The FDA product code for Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable 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 Baylis Medical Company, Inc. como candidato(a)

K251325VersaCross Connect™ Transseptal Dilator K241720VersaCross Connect™ Transseptal Dilator K231227SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath K233647VersaCross Connect™ Transseptal Dilator K213898ProTrack Pigtail Wire K221351Mechanical Guidewire

Ver todos os 18 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.