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FDA 510(k)

AQUADEX SYSTEM 100, MODEL A1100

K-Number: K040489 · 2004-04-27

ApplicantChf Solutions, Inc.
Decision Date2004-04-27
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AQUADEX SYSTEM 100, MODEL A1100 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 2004-04-27 under 510(k) number K040489. 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 AQUADEX SYSTEM 100, MODEL A1100?

AQUADEX SYSTEM 100, MODEL A1100 is a medical device that received FDA 510(k) clearance on 2004-04-27. The listed applicant is Chf Solutions, Inc.. The 510(k) number is K040489.

When did AQUADEX SYSTEM 100, MODEL A1100 receive FDA 510(k) clearance?

AQUADEX SYSTEM 100, MODEL A1100 received FDA 510(k) clearance on 2004-04-27, under 510(k) number K040489.

Who is the listed applicant for AQUADEX SYSTEM 100, MODEL A1100?

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 AQUADEX SYSTEM 100, MODEL A1100?

The FDA product code for AQUADEX SYSTEM 100, MODEL A1100 is KDI.

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Other records listing Chf Solutions, Inc. 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.

K192756Aquadex FlexFlow System 2.0K071854AQUADEX FLEXFLOW SYSTEMK070512MODIFICATION TO AQUADEX FLEXFLOW SYSTEMK062922MODIFICATION TO AQUADEX FLEXFLOW SYSTEMK060008AQUADEX FLEXFLOW SYSTEMK050609AQUADEX SYSTEM

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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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