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FDA 510(k)

GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS

K-Number: K955487 · 1997-04-18

ApplicantCobe Renal Care, Inc.
Decision Date1997-04-18
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS is the device name listed in this FDA 510(k) record. The listed applicant is Cobe Renal Care, Inc.. It received FDA 510(k) clearance on 1997-04-18 under 510(k) number K955487. 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 14, 17, & 21 HEMODIALYZERS?

GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS is a medical device that received FDA 510(k) clearance on 1997-04-18. The listed applicant is Cobe Renal Care, Inc.. The 510(k) number is K955487.

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

GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS received FDA 510(k) clearance on 1997-04-18, under 510(k) number K955487.

Who is the listed applicant for GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS?

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

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

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

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Other records listing Cobe Renal Care, 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.

K955497GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SETK955592COBE CENTRYSYSTEM 14 PES HEMODIALYZERSK946279PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)K954003COBE HEMODYNAMIC RECIRCULATION MONITORK960474COBE CENTRYSYSTEM 600 HG HEMODIALYZERSK944436COBE CENTRYSYSTEM CS 200 DIALYZER

View all 14 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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