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FDA 510(k)

PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)

K-Number: K970648 · 1998-01-05

ApplicantRenal Systems, Inc.
Decision Date1998-01-05
Product CodeMSF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S) is the device name listed in this FDA 510(k) record. The listed applicant is Renal Systems, Inc.. It received FDA 510(k) clearance on 1998-01-05 under 510(k) number K970648. 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 PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)?

PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S) is a medical device that received FDA 510(k) clearance on 1998-01-05. The listed applicant is Renal Systems, Inc.. The 510(k) number is K970648.

When did PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S) receive FDA 510(k) clearance?

PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S) received FDA 510(k) clearance on 1998-01-05, under 510(k) number K970648.

Who is the listed applicant for PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)?

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

What is the FDA product code for PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)?

The FDA product code for PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S) is MSF.

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Other records listing Renal Systems, 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.

K861730ACTRIL FOR KIDNEY MACHINE DISINFECTANTK854011RENALFO HEMOFILTER CAVHDK844790RENAFLO HEMOCONCENTRATORK843963DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWDK844108RENAL SYSTEMS PERITONEAL ACCESS SYSTEMK842258RENATRON

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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 HealthcareK970681ALTRA NOVA 200 HEMODIALYZERAlthin Medical AB an Affiliate of Baxter IntlK970679ALTRA FLUX 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 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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