FDA 510(k)

EXTRACORPOREAL BLOOD PUMPING SYST FOR HEMOFILTRAT

K-Number: K911315 · 1991-10-30

Decision Date1991-10-30

Product CodeKOC

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

EXTRACORPOREAL BLOOD PUMPING SYST FOR HEMOFILTRAT 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 1991-10-30 under 510(k) number K911315. The device is classified under product code KOC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTRACORPOREAL BLOOD PUMPING SYST FOR HEMOFILTRAT?

EXTRACORPOREAL BLOOD PUMPING SYST FOR HEMOFILTRAT is a medical device that received FDA 510(k) clearance on 1991-10-30. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K911315.

When did EXTRACORPOREAL BLOOD PUMPING SYST FOR HEMOFILTRAT receive FDA 510(k) clearance?

EXTRACORPOREAL BLOOD PUMPING SYST FOR HEMOFILTRAT received FDA 510(k) clearance on 1991-10-30, under 510(k) number K911315.

Who is the listed applicant for EXTRACORPOREAL BLOOD PUMPING SYST FOR HEMOFILTRAT?

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 EXTRACORPOREAL BLOOD PUMPING SYST FOR HEMOFILTRAT?

The FDA product code for EXTRACORPOREAL BLOOD PUMPING SYST FOR HEMOFILTRAT is KOC.

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Related Devices (Code: KOC)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.