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FDA 510(k)

GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR

K-Number: K023615 · 2003-05-06

ApplicantGambro Renal Products
Decision Date2003-05-06
Product CodeMSF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR is the device name listed in this FDA 510(k) record. The listed applicant is Gambro Renal Products. It received FDA 510(k) clearance on 2003-05-06 under 510(k) number K023615. The device is classified under product code MSF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR?

GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR is a medical device that received FDA 510(k) clearance on 2003-05-06. The listed applicant is Gambro Renal Products. The 510(k) number is K023615.

When did GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR receive FDA 510(k) clearance?

GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR received FDA 510(k) clearance on 2003-05-06, under 510(k) number K023615.

Who is the listed applicant for GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR?

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

What is the FDA product code for GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR?

The FDA product code for GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR is MSF.

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Other records listing Gambro Renal Products 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.

K120333PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPYK072908PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPYK070414GAMBRO CARTRIDGE BLOOD SETSK063290GAMBRO QUICKSET BLOODLINESK062090PRISMA SYSTEM R03.10AK060195GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE

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Related Devices (Code: MSF)

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/ FILTERGambro HealthcareK970679ALTRA FLUX 200 HEMODIALYZERAlthin Medical AB an Affiliate of Baxter IntlK970681ALTRA NOVA 200 HEMODIALYZERAlthin Medical AB an Affiliate of Baxter IntlK970662CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-170/CA-210)Baxter Healthcare CorpK970653CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)Baxter Healthcare CorpK970663CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G)Baxter Healthcare Corp

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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