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FDA 510(k)

GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER

K-Number: K994390 · 2000-10-26

ApplicantGambro Healthcare
Decision Date2000-10-26
Product CodeMSF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Gambro Healthcare. It received FDA 510(k) clearance on 2000-10-26 under 510(k) number K994390. 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 17R, CAPILLARY DIALYZER/ FILTER?

GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER is a medical device that received FDA 510(k) clearance on 2000-10-26. The listed applicant is Gambro Healthcare. The 510(k) number is K994390.

When did GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER receive FDA 510(k) clearance?

GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER received FDA 510(k) clearance on 2000-10-26, under 510(k) number K994390.

Who is the listed applicant for GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER?

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 17R, CAPILLARY DIALYZER/ FILTER?

The FDA product code for GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER is MSF.

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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.

K990039GAMBRO DQM 200K982413COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERSK982414GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERSK980386HOSPAL 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: 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.

K023615GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LRGambro Renal ProductsK970679ALTRA 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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