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FDA 510(k)

GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS

K-Number: K982414 · 1999-03-26

ApplicantGambro Healthcare
Decision Date1999-03-26
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS is the device name listed in this FDA 510(k) record. The listed applicant is Gambro Healthcare. It received FDA 510(k) clearance on 1999-03-26 under 510(k) number K982414. 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 GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS?

GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS is a medical device that received FDA 510(k) clearance on 1999-03-26. The listed applicant is Gambro Healthcare. The 510(k) number is K982414.

When did GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS receive FDA 510(k) clearance?

GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS received FDA 510(k) clearance on 1999-03-26, under 510(k) number K982414.

Who is the listed applicant for GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS?

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

What is the FDA product code for GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS?

The FDA product code for GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS is KDI.

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Other records listing Gambro Healthcare 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.

K994390GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTERK990039GAMBRO DQM 200K982413COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERSK980386HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0)K982760COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SETK982818HOSPAL TIPSTOP

View all 13 devices →

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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