Decision Date1978-08-31
Product CodeDJC
Advisory CommitteeTX
DecisionSubstantially Equivalent
Device Summary
KIDNEY, ARTIFICIAL, C-DAK 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corp.. It received FDA 510(k) clearance on 1978-08-31 under 510(k) number K781237. The device is classified under product code DJC. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the KIDNEY, ARTIFICIAL, C-DAK 2.0?
KIDNEY, ARTIFICIAL, C-DAK 2.0 is a medical device that received FDA 510(k) clearance on 1978-08-31. The listed applicant is Cordis Corp.. The 510(k) number is K781237.
When did KIDNEY, ARTIFICIAL, C-DAK 2.0 receive FDA 510(k) clearance?
KIDNEY, ARTIFICIAL, C-DAK 2.0 received FDA 510(k) clearance on 1978-08-31, under 510(k) number K781237.
Who is the listed applicant for KIDNEY, ARTIFICIAL, C-DAK 2.0?
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 KIDNEY, ARTIFICIAL, C-DAK 2.0?
The FDA product code for KIDNEY, ARTIFICIAL, C-DAK 2.0 is DJC.
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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.