FDA 510(k)

XenMatrix AB Surgical Graft

Número K: K162193 · 2016-12-23

Data da decisão2016-12-23

Código do produtoPIJ

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

XenMatrix AB Surgical Graft is the device name listed in this FDA 510(k) record. The listed applicant is C. R. Bard. It received FDA 510(k) clearance on 2016-12-23 under 510(k) number K162193. The device is classified under product code PIJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the XenMatrix AB Surgical Graft?

XenMatrix AB Surgical Graft is a medical device that received FDA 510(k) clearance on 2016-12-23. The listed applicant is C. R. Bard. The 510(k) number is K162193.

When did XenMatrix AB Surgical Graft receive FDA 510(k) clearance?

XenMatrix AB Surgical Graft received FDA 510(k) clearance on 2016-12-23, under 510(k) number K162193.

Who is the listed applicant for XenMatrix AB Surgical Graft?

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

What is the FDA product code for XenMatrix AB Surgical Graft?

The FDA product code for XenMatrix AB Surgical Graft is PIJ.

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