FDA 510(k)

LotusCatheter (Lotus No Balloon Catheter)

Número K: K191512 · 2020-05-21

RequerenteHakki Medical Technologies, Inc.

Data da decisão2020-05-21

Código do produtoGBM

Comité consultivoGU

DecisãoUnknown

Resumo do dispositivo

LotusCatheter (Lotus No Balloon Catheter) is the device name listed in this FDA 510(k) record. The listed applicant is Hakki Medical Technologies, Inc.. It received FDA 510(k) clearance on 2020-05-21 under 510(k) number K191512. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Perguntas frequentes

What is the LotusCatheter (Lotus No Balloon Catheter)?

LotusCatheter (Lotus No Balloon Catheter) is a medical device that received FDA 510(k) clearance on 2020-05-21. The listed applicant is Hakki Medical Technologies, Inc.. The 510(k) number is K191512.

When did LotusCatheter (Lotus No Balloon Catheter) receive FDA 510(k) clearance?

LotusCatheter (Lotus No Balloon Catheter) received FDA 510(k) clearance on 2020-05-21, under 510(k) number K191512.

Who is the listed applicant for LotusCatheter (Lotus No Balloon Catheter)?

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

What is the FDA product code for LotusCatheter (Lotus No Balloon Catheter)?

The FDA product code for LotusCatheter (Lotus No Balloon Catheter) is GBM.

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: GBM)

K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter CompactWell Lead Medical Co., Ltd.K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterConvatec Limited K211436Intermittent Catheter (Not Finalized)Hollister Incorporated K200820SpeediCath Compact SetColoplast K192904SpeediCath Compact SetColoplast K200142SpeediCath SoftColoplast

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.