FDA 510(k)

Lumina-PTFE Titanium

Número K: K221851 · 2023-12-08

RequerenteCriteria Industria E Comercio DE Produtos Medicinais

Data da decisão2023-12-08

Código do produtoNPK

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Lumina-PTFE Titanium is the device name listed in this FDA 510(k) record. The listed applicant is Criteria Industria E Comercio DE Produtos Medicinais. It received FDA 510(k) clearance on 2023-12-08 under 510(k) number K221851. The device is classified under product code NPK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Lumina-PTFE Titanium?

Lumina-PTFE Titanium is a medical device that received FDA 510(k) clearance on 2023-12-08. The listed applicant is Criteria Industria E Comercio DE Produtos Medicinais. The 510(k) number is K221851.

When did Lumina-PTFE Titanium receive FDA 510(k) clearance?

Lumina-PTFE Titanium received FDA 510(k) clearance on 2023-12-08, under 510(k) number K221851.

Who is the listed applicant for Lumina-PTFE Titanium?

The FDA 510(k) record lists Criteria Industria E Comercio DE Produtos Medicinais as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lumina-PTFE Titanium?

The FDA product code for Lumina-PTFE Titanium is NPK.

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: NPK)

K222549OpenTexPurgo Biologics, Inc.K211554InnoGenic Non-resorbable MembraneCowellmedi Co., Ltd.K210797Bio-MEM Ti Reinforced MembraneB&Medi Co., Ltd.K201187Cytoplast Titanium-Reinforced PTFE MembranesOsteogenics Biomedical, Inc.K171774RPM Reinforced PTFE MeshOsteogenics Biomedical, Inc.K160493Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mmSalvin Dental Specialties

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.