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FDA 510(k)

C-DAK 4000 ARTIFICIAL KIDNEY

K-Number: K781058 · 1978-08-23

ApplicantCordis Corp.
Decision Date1978-08-23
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

C-DAK 4000 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 1978-08-23 under 510(k) number K781058. 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 4000 ARTIFICIAL KIDNEY?

C-DAK 4000 ARTIFICIAL KIDNEY is a medical device that received FDA 510(k) clearance on 1978-08-23. The listed applicant is Cordis Corp.. The 510(k) number is K781058.

When did C-DAK 4000 ARTIFICIAL KIDNEY receive FDA 510(k) clearance?

C-DAK 4000 ARTIFICIAL KIDNEY received FDA 510(k) clearance on 1978-08-23, under 510(k) number K781058.

Who is the listed applicant for C-DAK 4000 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 4000 ARTIFICIAL KIDNEY?

The FDA product code for C-DAK 4000 ARTIFICIAL KIDNEY is FJI.

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Other records listing Cordis Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K190459Hemoflow F3 and F4 DialyzersFresenius Medical Care Renal Therapies Group, LLCK122952NIPRO PUREFLUX-L HEMODIALYZERNipro Medical CorporationK043342POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LRGambro Renal ProductsK010366DISPOSABLE STORAGE CAPMolded Products, Inc.K011148ULTRACONCENTRATOR SYSTEMInterpore Cross Intl.K002761FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERSFresenius Medical Care North America

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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