FDA 510(k)

Chameleon PTA Balloon Catheter

Número K: K170635 · 2017-03-30

Data da decisão2017-03-30

Código do produtoLIT

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Chameleon PTA Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Av Medical Technologies, Ltd.. It received FDA 510(k) clearance on 2017-03-30 under 510(k) number K170635. 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 Chameleon PTA Balloon Catheter?

Chameleon PTA Balloon Catheter is a medical device that received FDA 510(k) clearance on 2017-03-30. The listed applicant is Av Medical Technologies, Ltd.. The 510(k) number is K170635.

When did Chameleon PTA Balloon Catheter receive FDA 510(k) clearance?

Chameleon PTA Balloon Catheter received FDA 510(k) clearance on 2017-03-30, under 510(k) number K170635.

Who is the listed applicant for Chameleon PTA Balloon Catheter?

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

What is the FDA product code for Chameleon PTA Balloon Catheter?

The FDA product code for Chameleon PTA Balloon 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 Av Medical Technologies, Ltd. como candidato(a)

K163231Chameleon PTA Balloon Catheter

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.