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FDA 510(k)

ClearumTM HS

K-Number: K231406 · 2023-06-14

ApplicantBellco Srl
Decision Date2023-06-14
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ClearumTM HS is the device name listed in this FDA 510(k) record. The listed applicant is Bellco Srl. It received FDA 510(k) clearance on 2023-06-14 under 510(k) number K231406. 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 ClearumTM HS?

ClearumTM HS is a medical device that received FDA 510(k) clearance on 2023-06-14. The listed applicant is Bellco Srl. The 510(k) number is K231406.

When did ClearumTM HS receive FDA 510(k) clearance?

ClearumTM HS received FDA 510(k) clearance on 2023-06-14, under 510(k) number K231406.

Who is the listed applicant for ClearumTM HS?

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 ClearumTM HS?

The FDA product code for ClearumTM HS 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.

K193542Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22K160558RAPIDO HOLLOW-FIBRE DIALYZERS

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

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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