FDA 510(k)

CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90)

K-Number: K970661 · 1997-11-12

Decision Date1997-11-12

Product CodeMSE

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90) is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1997-11-12 under 510(k) number K970661. 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 CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90)?

CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90) is a medical device that received FDA 510(k) clearance on 1997-11-12. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K970661.

When did CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90) receive FDA 510(k) clearance?

CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90) received FDA 510(k) clearance on 1997-11-12, under 510(k) number K970661.

Who is the listed applicant for CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90)?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90)?

The FDA product code for CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90) is MSE.

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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.K970700FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUXFresenius USA, Inc.K97409095 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERSFresenius Medical Care North America 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.