FDA 510(k)

Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device

Número K: K190623 · 2019-05-30

Data da decisão2019-05-30

Código do produtoOCL

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen 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 2019-05-30 under 510(k) number K190623. 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 Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device?

Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device is a medical device that received FDA 510(k) clearance on 2019-05-30. The listed applicant is Medtronic. The 510(k) number is K190623.

When did Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device receive FDA 510(k) clearance?

Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device received FDA 510(k) clearance on 2019-05-30, under 510(k) number K190623.

Who is the listed applicant for Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen 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 Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device?

The FDA product code for Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device is OCL.

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Fonte oficial

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