FDA 510(k)

Dr. Amplatz Micro Plug

Número K: K182944 · 2019-04-17

Data da decisão2019-04-17

Código do produtoKRD

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Dr. Amplatz Micro Plug is the device name listed in this FDA 510(k) record. The listed applicant is Ka Medical, LLC. It received FDA 510(k) clearance on 2019-04-17 under 510(k) number K182944. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Dr. Amplatz Micro Plug?

Dr. Amplatz Micro Plug is a medical device that received FDA 510(k) clearance on 2019-04-17. The listed applicant is Ka Medical, LLC. The 510(k) number is K182944.

When did Dr. Amplatz Micro Plug receive FDA 510(k) clearance?

Dr. Amplatz Micro Plug received FDA 510(k) clearance on 2019-04-17, under 510(k) number K182944.

Who is the listed applicant for Dr. Amplatz Micro Plug?

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

What is the FDA product code for Dr. Amplatz Micro Plug?

The FDA product code for Dr. Amplatz Micro Plug is KRD.

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