FDA 510(k)

CHIRAVAC Blood Collection Needles

Número K: K201009 · 2021-07-21

Data da decisão2021-07-21

Código do produtoJKA

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

CHIRAVAC Blood Collection Needles is the device name listed in this FDA 510(k) record. The listed applicant is Chirana T. Injecta. It received FDA 510(k) clearance on 2021-07-21 under 510(k) number K201009. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CHIRAVAC Blood Collection Needles?

CHIRAVAC Blood Collection Needles is a medical device that received FDA 510(k) clearance on 2021-07-21. The listed applicant is Chirana T. Injecta. The 510(k) number is K201009.

When did CHIRAVAC Blood Collection Needles receive FDA 510(k) clearance?

CHIRAVAC Blood Collection Needles received FDA 510(k) clearance on 2021-07-21, under 510(k) number K201009.

Who is the listed applicant for CHIRAVAC Blood Collection Needles?

The FDA 510(k) record lists Chirana T. Injecta as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHIRAVAC Blood Collection Needles?

The FDA product code for CHIRAVAC Blood Collection Needles is JKA.

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 Chirana T. Injecta como candidato(a)

K242434Insulin Syringes K220614MEDOJECT fine Pen Needles K201044CHIRANA Insulin Syringes

Dispositivos Relacionados (Código: JKA)

K262215Profoject™ Safety Sliding Blood Collection SetCMT Health PTE., Ltd.K252899Female Culture Device; Male Culture Device; Transfer Device; Access DeviceZhejiang Kindly Medical Device Co., Ltd.K260128BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesBecton, Dickinson and Company K252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection TubeBecton, Dickinson and Company K252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached HolderBecton, Dickinson and Company K252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection TubesBecton, Dickinson and Company

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.