FDA 510(k)

Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter

Número K: K160941 · 2016-12-13

Data da decisão2016-12-13

Código do produtoLIT

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Brosmed Medical Co., Ltd.. It received FDA 510(k) clearance on 2016-12-13 under 510(k) number K160941. 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 Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter?

Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2016-12-13. The listed applicant is Brosmed Medical Co., Ltd.. The 510(k) number is K160941.

When did Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter receive FDA 510(k) clearance?

Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter received FDA 510(k) clearance on 2016-12-13, under 510(k) number K160941.

Who is the listed applicant for Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter?

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

What is the FDA product code for Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter?

The FDA product code for Castor, Achilles and Hermes NC 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

Outros registros que listam Brosmed Medical Co., Ltd. como candidato(a)

K243704Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter K241478Tri-Wedge PTA Scoring Balloon Dilatation Catheter K230705POT PTCA Balloon Dilatation Catheter K212215Tiche PTA Balloon Dilatation Catheter K203390Artimes pro Balloon Dilatation Catheter K153742Catheter de Dilatação Balão Apollo

Ver todos os 8 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 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.