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FDA 510(k)

XenMatrix AB Surgical Graft

K-Number: K162193 · 2016-12-23

ApplicantC. R. Bard
Decision Date2016-12-23
Product CodePIJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by C. R. Bard. The 510(k) number is K162193.

When was XenMatrix AB Surgical Graft approved by the FDA?

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

What company makes XenMatrix AB Surgical Graft?

XenMatrix AB Surgical Graft is manufactured by C. R. Bard.

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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