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FDA 510(k)

XTRA Autotransfusion System (with XTRA Bowl sets)

K-Number: K240584 · 2024-04-29

ApplicantSorin Group Italia S.R.L.
Decision Date2024-04-29
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

XTRA Autotransfusion System (with XTRA Bowl sets) is a medical device manufactured by Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2024-04-29 under approval number K240584. 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 XTRA Autotransfusion System (with XTRA Bowl sets)?

XTRA Autotransfusion System (with XTRA Bowl sets) is a medical device that received FDA 510(k) clearance on 2024-04-29. It is manufactured by Sorin Group Italia S.R.L.. The 510(k) number is K240584.

When was XTRA Autotransfusion System (with XTRA Bowl sets) approved by the FDA?

XTRA Autotransfusion System (with XTRA Bowl sets) received FDA 510(k) clearance on 2024-04-29, under approval number K240584.

What company makes XTRA Autotransfusion System (with XTRA Bowl sets)?

XTRA Autotransfusion System (with XTRA Bowl sets) is manufactured by Sorin Group Italia S.R.L..

What is the FDA product code for XTRA Autotransfusion System (with XTRA Bowl sets)?

The FDA product code for XTRA Autotransfusion System (with XTRA Bowl sets) is CAC.

Other Devices by Sorin Group Italia S.R.L.

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Related Devices (Code: CAC)

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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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