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FDA 510(k)

C-DAK DUO-FLUX ARTIFICIAL KIDNEY

K-Number: K801731 · 1980-08-13

ApplicantCordis Corp.
Decision Date1980-08-13
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

C-DAK DUO-FLUX 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 1980-08-13 under 510(k) number K801731. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C-DAK DUO-FLUX ARTIFICIAL KIDNEY?

C-DAK DUO-FLUX ARTIFICIAL KIDNEY is a medical device that received FDA 510(k) clearance on 1980-08-13. The listed applicant is Cordis Corp.. The 510(k) number is K801731.

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

C-DAK DUO-FLUX ARTIFICIAL KIDNEY received FDA 510(k) clearance on 1980-08-13, under 510(k) number K801731.

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

The FDA product code for C-DAK DUO-FLUX ARTIFICIAL KIDNEY is KDI.

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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: KDI)

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.

K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLCK252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLCK260533ELISIO™-HNipro Medical CorporationK252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLCK253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.K253518FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC

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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