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FDA 510(k)

SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT

K-Number: K024124 · 2003-03-14

ApplicantChf Solutions, Inc.
Decision Date2003-03-14
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT is the device name listed in this FDA 510(k) record. The listed applicant is Chf Solutions, Inc.. It received FDA 510(k) clearance on 2003-03-14 under 510(k) number K024124. 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 SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT?

SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT is a medical device that received FDA 510(k) clearance on 2003-03-14. The listed applicant is Chf Solutions, Inc.. The 510(k) number is K024124.

When did SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT receive FDA 510(k) clearance?

SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT received FDA 510(k) clearance on 2003-03-14, under 510(k) number K024124.

Who is the listed applicant for SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT?

The FDA 510(k) record lists Chf Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT?

The FDA product code for SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT is KDI.

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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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