FDA 510(k)

FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX

K-Number: K970700 · 1998-09-15

Decision Date1998-09-15

Product CodeMSE

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius USA, Inc.. It received FDA 510(k) clearance on 1998-09-15 under 510(k) number K970700. 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 FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX?

FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX is a medical device that received FDA 510(k) clearance on 1998-09-15. The listed applicant is Fresenius USA, Inc.. The 510(k) number is K970700.

When did FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX receive FDA 510(k) clearance?

FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX received FDA 510(k) clearance on 1998-09-15, under 510(k) number K970700.

Who is the listed applicant for FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX?

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

What is the FDA product code for FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX?

The FDA product code for FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX is MSE.

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Other records listing Fresenius USA, Inc. as applicant

K992275FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS K974584FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS K973378C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61 K9614652008H ON LINE CLEARANCE MONITOR K961706P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR K955762PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM

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Related Devices (Code: MSE)

K001685PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210Baxter Healthcare Corp K983720ASAHI 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.K97409095 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERSFresenius Medical Care North America K970661CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90)Baxter Healthcare Corp K970654CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)Baxter Healthcare Corp K970650ASAHI 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.