Aviso: Este site agrega dados públicos oficiais da FDA, ClinicalTrials.gov, PubMed e SEC EDGAR apenas para referência geral. Não constitui aconselhamento médico, diagnóstico, recomendação de tratamento ou aconselhamento de investimento.

FDA 510(k)

MitraPatch Mitral Valve Repair System

Número K: K252126 · 2025-12-04

RequerenteChawla Heart Technologies, LLC
Data da decisão2025-12-04
Código do produtoPAW
Comité consultivoCV
DecisãoSubstantially Equivalent

Resumo do dispositivo

MitraPatch Mitral Valve Repair System is the device name listed in this FDA 510(k) record. The listed applicant is Chawla Heart Technologies, LLC. It received FDA 510(k) clearance on 2025-12-04 under 510(k) number K252126. The device is classified under product code PAW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MitraPatch Mitral Valve Repair System?

MitraPatch Mitral Valve Repair System is a medical device that received FDA 510(k) clearance on 2025-12-04. The listed applicant is Chawla Heart Technologies, LLC. The 510(k) number is K252126.

When did MitraPatch Mitral Valve Repair System receive FDA 510(k) clearance?

MitraPatch Mitral Valve Repair System received FDA 510(k) clearance on 2025-12-04, under 510(k) number K252126.

Who is the listed applicant for MitraPatch Mitral Valve Repair System?

The FDA 510(k) record lists Chawla Heart Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MitraPatch Mitral Valve Repair System?

The FDA product code for MitraPatch Mitral Valve Repair System is PAW.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

↑