FDA 510(k)

Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover

Número K: K152342 · 2016-06-09

Data da decisão2016-06-09

Código do produtoGXR

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover is the device name listed in this FDA 510(k) record. The listed applicant is St Jude Medical. It received FDA 510(k) clearance on 2016-06-09 under 510(k) number K152342. The device is classified under product code GXR. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover?

Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover is a medical device that received FDA 510(k) clearance on 2016-06-09. The listed applicant is St Jude Medical. The 510(k) number is K152342.

When did Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover receive FDA 510(k) clearance?

Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover received FDA 510(k) clearance on 2016-06-09, under 510(k) number K152342.

Who is the listed applicant for Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover?

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

What is the FDA product code for Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover?

The FDA product code for Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover is GXR.

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Fonte oficial

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