FDA 510(k)

XVAC

K-Number: K110782 · 2011-04-07

Decision Date2011-04-07

Product CodeCAC

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

XVAC is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2011-04-07 under 510(k) number K110782. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XVAC?

XVAC is a medical device that received FDA 510(k) clearance on 2011-04-07. The listed applicant is Sorin Group Italia S.R.L.. The 510(k) number is K110782.

When did XVAC receive FDA 510(k) clearance?

XVAC received FDA 510(k) clearance on 2011-04-07, under 510(k) number K110782.

Who is the listed applicant for XVAC?

The FDA 510(k) record lists Sorin Group Italia S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XVAC?

The FDA product code for XVAC is CAC.

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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.