FDA 510(k)

Bomba Balão Intra-Aórtico da Série AC3

Número K: K192238 · 2019-11-12

Data da decisão2019-11-12

Código do produtoDSP

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

AC3 Series Intra-Aortic Balloon Pump (IABP) is the device name listed in this FDA 510(k) record. The listed applicant is Arrow International, Teleflex. It received FDA 510(k) clearance on 2019-11-12 under 510(k) number K192238. The device is classified under product code DSP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AC3 Series Intra-Aortic Balloon Pump (IABP)?

AC3 Series Intra-Aortic Balloon Pump (IABP) is a medical device that received FDA 510(k) clearance on 2019-11-12. The listed applicant is Arrow International, Teleflex. The 510(k) number is K192238.

When did AC3 Series Intra-Aortic Balloon Pump (IABP) receive FDA 510(k) clearance?

AC3 Series Intra-Aortic Balloon Pump (IABP) received FDA 510(k) clearance on 2019-11-12, under 510(k) number K192238.

Who is the listed applicant for AC3 Series Intra-Aortic Balloon Pump (IABP)?

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

What is the FDA product code for AC3 Series Intra-Aortic Balloon Pump (IABP)?

The FDA product code for AC3 Series Intra-Aortic Balloon Pump (IABP) is DSP.

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

Dispositivos Relacionados (Código: DSP)

K250542Bomba Balão Intra-Aórtico da Série AC3 RangeArrow International, LLC K232343Bomba Balão Intra-Aórtico da Série AC3Arrow International, LLC K201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPArrow International, Inc.K200634Arrow FiberOptix Intra-Aortic Balloon Catheter KitArrow International, Inc.K190101UltraFlex IABArrow International, Inc.K190117Fiberoptix IABArrow International, 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.