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FDA 510(k)

95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS

K-Number: K974090 · 1998-08-27

ApplicantFresenius Medical Care North America
Decision Date1998-08-27
Product CodeMSE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care North America. It received FDA 510(k) clearance on 1998-08-27 under 510(k) number K974090. The device is classified under product code MSE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS?

95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS is a medical device that received FDA 510(k) clearance on 1998-08-27. The listed applicant is Fresenius Medical Care North America. The 510(k) number is K974090.

When did 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS receive FDA 510(k) clearance?

95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS received FDA 510(k) clearance on 1998-08-27, under 510(k) number K974090.

Who is the listed applicant for 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS?

The FDA 510(k) record lists Fresenius Medical Care North America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS?

The FDA product code for 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS is MSE.

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Other records listing Fresenius Medical Care North America 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.

K252181AquaAK162488Optiflux dialyzerK131611FRESENIUS DRY ACID DISSOLUTION UNITSK1240352008K@HOME HEMODIALYSIS MACHINEK121341FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEMK121599CRIT-LINE CLIP (CLIC)

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Related Devices (Code: MSE)

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.

K001685PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210Baxter Healthcare CorpK983720ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, AND AM-BIO-100, AM-BIO-Asahi Medical Co., Ltd.K970700FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUXFresenius USA, Inc.K970661CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90)Baxter Healthcare CorpK970654CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)Baxter Healthcare CorpK970650ASAHI AM-R SERIES DIALYZERSAsahi Medical Co., Ltd.

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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