FDA 510(k)

Conjunto de Infusão de Segurança Pro-Lock CT 20G x 5/8

Número K: K171333 · 2017-07-18

RequerenteMedcomp (Dba Medical Components, Inc.)

Data da decisão2017-07-18

Código do produtoPTI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

20G x 5/8 Pro-Lock CT Safety Infusion Set is the device name listed in this FDA 510(k) record. The listed applicant is Medcomp (Dba Medical Components, Inc.). It received FDA 510(k) clearance on 2017-07-18 under 510(k) number K171333. 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 20G x 5/8 Pro-Lock CT Safety Infusion Set?

20G x 5/8 Pro-Lock CT Safety Infusion Set is a medical device that received FDA 510(k) clearance on 2017-07-18. The listed applicant is Medcomp (Dba Medical Components, Inc.). The 510(k) number is K171333.

When did 20G x 5/8 Pro-Lock CT Safety Infusion Set receive FDA 510(k) clearance?

20G x 5/8 Pro-Lock CT Safety Infusion Set received FDA 510(k) clearance on 2017-07-18, under 510(k) number K171333.

Who is the listed applicant for 20G x 5/8 Pro-Lock CT Safety Infusion Set?

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

What is the FDA product code for 20G x 5/8 Pro-Lock CT Safety Infusion Set?

The FDA product code for 20G x 5/8 Pro-Lock CT Safety Infusion 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 Medcomp (Dba Medical Components, Inc.) como candidato(a)

K171483ArquFlo CT Midline K171618Symetrex Long Term Hemodialysis Catheter

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.K241353PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle SetBard Access Systems, Inc.K230715Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd.

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.