FDA 510(k)

Cateter de Dilatação de Balão All’InCath 035M PTA

Número K: K191275 · 2020-01-15

Data da decisão2020-01-15

Código do produtoLIT

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

All’InCath 035M PTA Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Nexstep Medical. It received FDA 510(k) clearance on 2020-01-15 under 510(k) number K191275. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the All’InCath 035M PTA Balloon Dilatation Catheter?

All’InCath 035M PTA Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2020-01-15. The listed applicant is Nexstep Medical. The 510(k) number is K191275.

When did All’InCath 035M PTA Balloon Dilatation Catheter receive FDA 510(k) clearance?

All’InCath 035M PTA Balloon Dilatation Catheter received FDA 510(k) clearance on 2020-01-15, under 510(k) number K191275.

Who is the listed applicant for All’InCath 035M PTA Balloon Dilatation Catheter?

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

What is the FDA product code for All’InCath 035M PTA Balloon Dilatation Catheter?

The FDA product code for All’InCath 035M PTA Balloon Dilatation Catheter is LIT.

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: 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 K252512Armada™ 14 NC PTA CatheterABBOTT 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.

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.