FDA 510(k)

CATSmart

K-Number: K192368 · 2019-09-27

Decision Date2019-09-27

Product CodeCAC

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

CATSmart is a medical device manufactured by Fresenius Kabi AG. It received FDA 510(k) clearance on 2019-09-27 under approval number K192368. 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 CATSmart?

CATSmart is a medical device that received FDA 510(k) clearance on 2019-09-27. It is manufactured by Fresenius Kabi AG. The 510(k) number is K192368.

When was CATSmart approved by the FDA?

CATSmart received FDA 510(k) clearance on 2019-09-27, under approval number K192368.

What company makes CATSmart?

CATSmart is manufactured by Fresenius Kabi AG.

What is the FDA product code for CATSmart?

The FDA product code for CATSmart is CAC.

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Related Devices (Code: CAC)

K160735CATSmartFresenius Kabi AG K160197Haemonetics Cell Saver Elite Autotransfusion SystemHaemonetics Corporation K162423Haemonetics Cell Saver Elite/Elite+ Autotransfusion SystemHaemonetics Corporation K180831CATSmartFresenius Kabi AG K181954autoLog IQ Autotransfusion SystemMedtronic Perfusion Systems K193361ProCell Surgical Sponge-Blood Recovery UnitProcell Surgical, Inc.

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.