FDA 510(k)

PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set

Número K: K241353 · 2024-11-27

Data da decisão2024-11-27

Código do produtoPTI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set is the device name listed in this FDA 510(k) record. The listed applicant is Bard Access Systems, Inc.. It received FDA 510(k) clearance on 2024-11-27 under 510(k) number K241353. The device is classified under product code PTI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set?

PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set is a medical device that received FDA 510(k) clearance on 2024-11-27. The listed applicant is Bard Access Systems, Inc.. The 510(k) number is K241353.

When did PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set receive FDA 510(k) clearance?

PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set received FDA 510(k) clearance on 2024-11-27, under 510(k) number K241353.

Who is the listed applicant for PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set?

The FDA 510(k) record lists Bard Access Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set?

The FDA product code for PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set is PTI.

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 Bard Access Systems, Inc. como candidato(a)

K252478Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable Port K251253PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable Port K242328PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports K240146BD Prevue™ II Peripheral Vascular Access System K222232Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly K210264BD PowerPiCC Catheter

Ver todos os 7 dispositivos →

Dispositivos Relacionados (Código: PTI)

K25409525G Huber NeedleMartech Medical Products K252355K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSb-Kawasumi Laboratories, Inc.K251138Promisemed Safety Huber NeedlesPromisemed Hangzhou Meditech Co., Ltd.K243332Promisemed Safety Huber NeedlesPromisemed Hangzhou Meditech Co., Ltd.K230715Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd.K213823Intera Refill KitIntera Oncology, 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.