FDA 510(k)

EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter

Número K: K210313 · 2022-12-30

RequerenteShanghai Microport EP Medtech Co., Ltd.

Data da decisão2022-12-30

Código do produtoDRF

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Microport EP Medtech Co., Ltd.. It received FDA 510(k) clearance on 2022-12-30 under 510(k) number K210313. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter?

EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter is a medical device that received FDA 510(k) clearance on 2022-12-30. The listed applicant is Shanghai Microport EP Medtech Co., Ltd.. The 510(k) number is K210313.

When did EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter receive FDA 510(k) clearance?

EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter received FDA 510(k) clearance on 2022-12-30, under 510(k) number K210313.

Who is the listed applicant for EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter?

The FDA 510(k) record lists Shanghai Microport EP Medtech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter?

The FDA product code for EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter is DRF.

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