FDA 510(k)

ProtekDilate Vascular Access Kit

Número K: K253616 · 2025-12-19

Data da decisão2025-12-19

Código do produtoDRE

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

ProtekDilate Vascular Access Kit is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K253616. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ProtekDilate Vascular Access Kit?

ProtekDilate Vascular Access Kit is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is Sorin Group Italia S.R.L.. The 510(k) number is K253616.

When did ProtekDilate Vascular Access Kit receive FDA 510(k) clearance?

ProtekDilate Vascular Access Kit received FDA 510(k) clearance on 2025-12-19, under 510(k) number K253616.

Who is the listed applicant for ProtekDilate Vascular Access Kit?

The FDA 510(k) record lists Sorin Group Italia S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ProtekDilate Vascular Access Kit?

The FDA product code for ProtekDilate Vascular Access Kit is DRE.

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 Sorin Group Italia S.R.L. como candidato(a)

K253671Dual Stage Venous Cannulae K251783Inspire HCR and HCR DUAL cardiotomy reservoirs K250610Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)K250150VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)K243264DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)K242953KIDS Arterial Filters

Ver todos os 24 dispositivos →

Dispositivos Relacionados (Código: DRE)

K261310FlexTract Deflectable-Rotational Dilator Sheath SetMerit Medical Systems, Inc.K251325VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K242229Micro Ace Gold Advanced Micro Access SystemMerit Medical Systems, Inc.K241720VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K233647VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K232609Micro Ace™ Advanced Micro Access SystemMerit Medical Systems, 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.