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FDA 510(k)

ALTRA NOVA 200 HEMODIALYZER

K-Number: K970681 · 1998-07-23

ApplicantAlthin Medical AB an Affiliate of Baxter Intl
Decision Date1998-07-23
Product CodeMSF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ALTRA NOVA 200 HEMODIALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Althin Medical AB an Affiliate of Baxter Intl. It received FDA 510(k) clearance on 1998-07-23 under 510(k) number K970681. 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 ALTRA NOVA 200 HEMODIALYZER?

ALTRA NOVA 200 HEMODIALYZER is a medical device that received FDA 510(k) clearance on 1998-07-23. The listed applicant is Althin Medical AB an Affiliate of Baxter Intl. The 510(k) number is K970681.

When did ALTRA NOVA 200 HEMODIALYZER receive FDA 510(k) clearance?

ALTRA NOVA 200 HEMODIALYZER received FDA 510(k) clearance on 1998-07-23, under 510(k) number K970681.

Who is the listed applicant for ALTRA NOVA 200 HEMODIALYZER?

The FDA 510(k) record lists Althin Medical AB an Affiliate of Baxter Intl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALTRA NOVA 200 HEMODIALYZER?

The FDA product code for ALTRA NOVA 200 HEMODIALYZER is MSF.

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Other records listing Althin Medical AB an Affiliate of Baxter Intl 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.

K990643PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015K970679ALTRA FLUX 200 HEMODIALYZERK970446DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEMK964922DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE DELIVERY SYSTEMK955384DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE LUMEN OPTIONK962309ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS

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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.

K023615GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LRGambro Renal ProductsK994390GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTERGambro HealthcareK970679ALTRA FLUX 200 HEMODIALYZERAlthin Medical AB an Affiliate of Baxter IntlK970653CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)Baxter Healthcare CorpK970662CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-170/CA-210)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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