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FDA 510(k)

C-DAK 2100 ARTIFICIAL KIDNEY

K-Number: K792419 · 1980-01-16

ApplicantCordis Corp.
Decision Date1980-01-16
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

C-DAK 2100 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 1980-01-16 under 510(k) number K792419. 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 C-DAK 2100 ARTIFICIAL KIDNEY?

C-DAK 2100 ARTIFICIAL KIDNEY is a medical device that received FDA 510(k) clearance on 1980-01-16. The listed applicant is Cordis Corp.. The 510(k) number is K792419.

When did C-DAK 2100 ARTIFICIAL KIDNEY receive FDA 510(k) clearance?

C-DAK 2100 ARTIFICIAL KIDNEY received FDA 510(k) clearance on 1980-01-16, under 510(k) number K792419.

Who is the listed applicant for C-DAK 2100 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 2100 ARTIFICIAL KIDNEY?

The FDA product code for C-DAK 2100 ARTIFICIAL KIDNEY is FJI.

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Other records listing Cordis Corp. as applicant

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K112797POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETERK101651ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIREK082143MICRO GUIDE CATHETER XPK062798SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MBK060877PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAXK050645CORDIS AMIIA .014 PTA BALLOON CATHETER

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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.

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