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FDA 510(k)

Purema® H Hemoconcentrator (EtO Sterilized)

K-Number: K232171 · 2024-02-07

ApplicantTecnoideal America
Decision Date2024-02-07
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Purema® H Hemoconcentrator (EtO Sterilized) is the device name listed in this FDA 510(k) record. The listed applicant is Tecnoideal America. It received FDA 510(k) clearance on 2024-02-07 under 510(k) number K232171. 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 Purema® H Hemoconcentrator (EtO Sterilized)?

Purema® H Hemoconcentrator (EtO Sterilized) is a medical device that received FDA 510(k) clearance on 2024-02-07. The listed applicant is Tecnoideal America. The 510(k) number is K232171.

When did Purema® H Hemoconcentrator (EtO Sterilized) receive FDA 510(k) clearance?

Purema® H Hemoconcentrator (EtO Sterilized) received FDA 510(k) clearance on 2024-02-07, under 510(k) number K232171.

Who is the listed applicant for Purema® H Hemoconcentrator (EtO Sterilized)?

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

What is the FDA product code for Purema® H Hemoconcentrator (EtO Sterilized)?

The FDA product code for Purema® H Hemoconcentrator (EtO Sterilized) is KDI.

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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