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FDA 510(k)

CATSmart, Automated Blood Processing Autotransfusion System

K-Number: K210089 · 2021-02-11

ApplicantFresenius Kabi AG
Decision Date2021-02-11
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CATSmart, Automated Blood Processing Autotransfusion System is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Kabi AG. It received FDA 510(k) clearance on 2021-02-11 under 510(k) number K210089. 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, Automated Blood Processing Autotransfusion System?

CATSmart, Automated Blood Processing Autotransfusion System is a medical device that received FDA 510(k) clearance on 2021-02-11. The listed applicant is Fresenius Kabi AG. The 510(k) number is K210089.

When did CATSmart, Automated Blood Processing Autotransfusion System receive FDA 510(k) clearance?

CATSmart, Automated Blood Processing Autotransfusion System received FDA 510(k) clearance on 2021-02-11, under 510(k) number K210089.

Who is the listed applicant for CATSmart, Automated Blood Processing Autotransfusion System?

The FDA 510(k) record lists Fresenius Kabi AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CATSmart, Automated Blood Processing Autotransfusion System?

The FDA product code for CATSmart, Automated Blood Processing Autotransfusion System is CAC.

Other records listing Fresenius Kabi AG as applicant

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Related Devices (Code: CAC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241236XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L.K240426Aventus Clot Management SystemInquis MedicalK240584XTRA Autotransfusion System (with XTRA Bowl sets)Sorin Group Italia S.R.L.K231782FlowSaver Blood Return System (80-101)Inari Medical, Inc.K221483FlowSaver Blood Return SystemInari Medical, Inc.K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)Haemonetics Corporation

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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