Decision Date2018-01-24
Product CodeKDJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Cycler Drain Bag Set is a medical device manufactured by Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2018-01-24 under approval number K173363. The device is classified under product code KDJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Cycler Drain Bag Set?
Cycler Drain Bag Set is a medical device that received FDA 510(k) clearance on 2018-01-24. It is manufactured by Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K173363.
When was Cycler Drain Bag Set approved by the FDA?
Cycler Drain Bag Set received FDA 510(k) clearance on 2018-01-24, under approval number K173363.
What company makes Cycler Drain Bag Set?
Cycler Drain Bag Set is manufactured by Fresenius Medical Care Renal Therapies Group, LLC.
What is the FDA product code for Cycler Drain Bag Set?
The FDA product code for Cycler Drain Bag Set is KDJ.
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Official Source
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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.