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FDA 510(k)

HemoCare Hemodialysis System

K-Number: K233557 · 2024-07-12

ApplicantDeka Research and Development
Decision Date2024-07-12
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HemoCare Hemodialysis System is a medical device manufactured by Deka Research and Development. It received FDA 510(k) clearance on 2024-07-12 under approval number K233557. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HemoCare Hemodialysis System?

HemoCare Hemodialysis System is a medical device that received FDA 510(k) clearance on 2024-07-12. It is manufactured by Deka Research and Development. The 510(k) number is K233557.

When was HemoCare Hemodialysis System approved by the FDA?

HemoCare Hemodialysis System received FDA 510(k) clearance on 2024-07-12, under approval number K233557.

What company makes HemoCare Hemodialysis System?

HemoCare Hemodialysis System is manufactured by Deka Research and Development.

What is the FDA product code for HemoCare Hemodialysis System?

The FDA product code for HemoCare Hemodialysis System is KDI.

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Other Devices by Deka Research and Development

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Related Devices (Code: KDI)

K160558RAPIDO HOLLOW-FIBRE DIALYZERSBellco Srl K160881Tablo ConsoleOutset Medical, Inc. K1534492008K2 Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC K152938DBB-06 Hemodialysis Delivery SystemNIKKISO CO., LTD. K143482xevonta dialyzerB. Braun Avitum AG K170790SAM CRRT Unit, SAM Cassette CRRTSpectral Medical, Inc.

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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