FDA 510(k)

Cardioblate Gemini-s Surgical Ablation Device

Número K: K200514 · 2020-06-03

Data da decisão2020-06-03

Código do produtoOCL

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Cardioblate Gemini-s Surgical Ablation Device is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic. It received FDA 510(k) clearance on 2020-06-03 under 510(k) number K200514. The device is classified under product code OCL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Cardioblate Gemini-s Surgical Ablation Device?

Cardioblate Gemini-s Surgical Ablation Device is a medical device that received FDA 510(k) clearance on 2020-06-03. The listed applicant is Medtronic. The 510(k) number is K200514.

When did Cardioblate Gemini-s Surgical Ablation Device receive FDA 510(k) clearance?

Cardioblate Gemini-s Surgical Ablation Device received FDA 510(k) clearance on 2020-06-03, under 510(k) number K200514.

Who is the listed applicant for Cardioblate Gemini-s Surgical Ablation Device?

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

What is the FDA product code for Cardioblate Gemini-s Surgical Ablation Device?

The FDA product code for Cardioblate Gemini-s Surgical Ablation Device is OCL.

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Fonte oficial

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