FDA 510(k)

ALYTE Y-MESH GRAFT

K-Number: K101722 · 2011-04-01

Decision Date2011-04-01

Product CodeOTO

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ALYTE Y-MESH GRAFT 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 2011-04-01 under 510(k) number K101722. The device is classified under product code OTO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALYTE Y-MESH GRAFT?

ALYTE Y-MESH GRAFT is a medical device that received FDA 510(k) clearance on 2011-04-01. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K101722.

When did ALYTE Y-MESH GRAFT receive FDA 510(k) clearance?

ALYTE Y-MESH GRAFT received FDA 510(k) clearance on 2011-04-01, under 510(k) number K101722.

Who is the listed applicant for ALYTE Y-MESH GRAFT?

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 ALYTE Y-MESH GRAFT?

The FDA product code for ALYTE Y-MESH GRAFT is OTO.

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Official Source

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