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FDA 510(k)

SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET

K-Number: K013733 · 2002-06-03

ApplicantChf Solutions, Inc.
Decision Date2002-06-03
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET 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 2002-06-03 under 510(k) number K013733. 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; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET?

SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET is a medical device that received FDA 510(k) clearance on 2002-06-03. The listed applicant is Chf Solutions, Inc.. The 510(k) number is K013733.

When did SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET receive FDA 510(k) clearance?

SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET received FDA 510(k) clearance on 2002-06-03, under 510(k) number K013733.

Who is the listed applicant for SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET?

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; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET?

The FDA product code for SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET 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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