FDA 510(k)

Phasix ST Mesh with Open Positioning System

Número K: K190185 · 2019-06-12

Data da decisão2019-06-12

Código do produtoOWT

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Phasix ST Mesh with Open Positioning System is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2019-06-12 under 510(k) number K190185. The device is classified under product code OWT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Phasix ST Mesh with Open Positioning System?

Phasix ST Mesh with Open Positioning System is a medical device that received FDA 510(k) clearance on 2019-06-12. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K190185.

When did Phasix ST Mesh with Open Positioning System receive FDA 510(k) clearance?

Phasix ST Mesh with Open Positioning System received FDA 510(k) clearance on 2019-06-12, under 510(k) number K190185.

Who is the listed applicant for Phasix ST Mesh with Open Positioning System?

The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Phasix ST Mesh with Open Positioning System?

The FDA product code for Phasix ST Mesh with Open Positioning System is OWT.

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