FDA 510(k)

MODEL CA.150 CELLULOSE ACETATE HOLLOW FIBER DIALYZ

K-Number: K905228 · 1990-12-10

Decision Date1990-12-10

Product CodeFJI

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

MODEL CA.150 CELLULOSE ACETATE HOLLOW FIBER DIALYZ 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 1990-12-10 under 510(k) number K905228. The device is classified under product code FJI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL CA.150 CELLULOSE ACETATE HOLLOW FIBER DIALYZ?

MODEL CA.150 CELLULOSE ACETATE HOLLOW FIBER DIALYZ is a medical device that received FDA 510(k) clearance on 1990-12-10. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K905228.

When did MODEL CA.150 CELLULOSE ACETATE HOLLOW FIBER DIALYZ receive FDA 510(k) clearance?

MODEL CA.150 CELLULOSE ACETATE HOLLOW FIBER DIALYZ received FDA 510(k) clearance on 1990-12-10, under 510(k) number K905228.

Who is the listed applicant for MODEL CA.150 CELLULOSE ACETATE HOLLOW FIBER DIALYZ?

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 MODEL CA.150 CELLULOSE ACETATE HOLLOW FIBER DIALYZ?

The FDA product code for MODEL CA.150 CELLULOSE ACETATE HOLLOW FIBER DIALYZ is FJI.

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Related Devices (Code: FJI)

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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.