Decision Date1983-03-29
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
C-DAK ARTIFICIAL KIDNEY is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corp.. It received FDA 510(k) clearance on 1983-03-29 under 510(k) number K830729. 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 C-DAK ARTIFICIAL KIDNEY?
C-DAK ARTIFICIAL KIDNEY is a medical device that received FDA 510(k) clearance on 1983-03-29. The listed applicant is Cordis Corp.. The 510(k) number is K830729.
When did C-DAK ARTIFICIAL KIDNEY receive FDA 510(k) clearance?
C-DAK ARTIFICIAL KIDNEY received FDA 510(k) clearance on 1983-03-29, under 510(k) number K830729.
Who is the listed applicant for C-DAK ARTIFICIAL KIDNEY?
The FDA 510(k) record lists Cordis Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for C-DAK ARTIFICIAL KIDNEY?
The FDA product code for C-DAK ARTIFICIAL KIDNEY is KOC.
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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.