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FDA 510(k)

RAPIDO HOLLOW-FIBRE DIALYZERS

K-Number: K160558 · 2016-11-18

ApplicantBellco Srl
Decision Date2016-11-18
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RAPIDO HOLLOW-FIBRE DIALYZERS is the device name listed in this FDA 510(k) record. The listed applicant is Bellco Srl. It received FDA 510(k) clearance on 2016-11-18 under 510(k) 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. The listed applicant is Bellco Srl. The 510(k) number is K160558.

When did RAPIDO HOLLOW-FIBRE DIALYZERS receive FDA 510(k) clearance?

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

Who is the listed applicant for RAPIDO HOLLOW-FIBRE DIALYZERS?

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

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

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

Other records listing Bellco Srl 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.

K231406ClearumTM HSK193542Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22

Related Devices (Code: KDI)

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.

K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLCK252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLCK260533ELISIO™-HNipro Medical CorporationK252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLCK253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.K253518FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC

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.

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