FDA 510(k)

POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE

K-Number: K040255 · 2004-05-24

Decision Date2004-05-24

Product CodeKDI

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE is the device name listed in this FDA 510(k) record. The listed applicant is Gambro Renal Products, Inc.. It received FDA 510(k) clearance on 2004-05-24 under 510(k) number K040255. 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 POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE?

POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE is a medical device that received FDA 510(k) clearance on 2004-05-24. The listed applicant is Gambro Renal Products, Inc.. The 510(k) number is K040255.

When did POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE receive FDA 510(k) clearance?

POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE received FDA 510(k) clearance on 2004-05-24, under 510(k) number K040255.

Who is the listed applicant for POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE?

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

What is the FDA product code for POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE?

The FDA product code for POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE is KDI.

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Other records listing Gambro Renal Products, Inc. as applicant

K130039REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER K113313MOLECULAR ADSORBENT RECIRCULATING(MARS)K110823PRISMAFLEX K103832PHOENIX HEMODIALYSIS DELIVERY SYSTEM K100451GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132 K100364GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520

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Related Devices (Code: KDI)

K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLC K252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLC K260533ELISIO™-HNipro Medical Corporation K252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLC K253412Tablo 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.