FDA 510(k)

RAPIDO HOLLOW-FIBRE DIALYZERS

K-Number: K160558 · 2016-11-18

Decision Date2016-11-18

Product CodeKDI

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

RAPIDO HOLLOW-FIBRE DIALYZERS is a medical device manufactured by Bellco Srl. It received FDA 510(k) clearance on 2016-11-18 under approval number K160558. 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 RAPIDO HOLLOW-FIBRE DIALYZERS?

RAPIDO HOLLOW-FIBRE DIALYZERS is a medical device that received FDA 510(k) clearance on 2016-11-18. It is manufactured by Bellco Srl. The 510(k) number is K160558.

When was RAPIDO HOLLOW-FIBRE DIALYZERS approved by the FDA?

RAPIDO HOLLOW-FIBRE DIALYZERS received FDA 510(k) clearance on 2016-11-18, under approval number K160558.

What company makes RAPIDO HOLLOW-FIBRE DIALYZERS?

RAPIDO HOLLOW-FIBRE DIALYZERS is manufactured by Bellco Srl.

What is the FDA product code for RAPIDO HOLLOW-FIBRE DIALYZERS?

The FDA product code for RAPIDO HOLLOW-FIBRE DIALYZERS is KDI.

Other Devices by Bellco Srl

K193542Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22 K231406ClearumTM HS

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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. K171331NxStage System OneNxstage Medical, 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.