Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CATSmart

K-Number: K160735 · 2016-09-16

ApplicantFresenius Kabi AG
Decision Date2016-09-16
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CATSmart 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 2016-09-16 under 510(k) number K160735. 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 2016-09-16. The listed applicant is Fresenius Kabi AG. The 510(k) number is K160735.

When did CATSmart receive FDA 510(k) clearance?

CATSmart received FDA 510(k) clearance on 2016-09-16, under 510(k) number K160735.

Who is the listed applicant for CATSmart?

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?

The FDA product code for CATSmart is CAC.

Other records listing Fresenius Kabi AG as applicant

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.

K251139KabiHelp® Uno; KabiHelp® Advance plusK221121Volumat Polyethylene I.V. Administration SetK220301Volumat LineK212445freeflex+ Transfer AdapterK210075Vigilant Software Suite – Vigilant Master MedK210074Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable

View all 13 devices →

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.

↑