15L Cycler Drainage Bag
K-Number: K214016 · 2022-03-18
ApplicantBaxter Healthcare Corporation
Decision Date2022-03-18
Product CodeKDJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
15L Cycler Drainage Bag is a medical device manufactured by Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2022-03-18 under approval number K214016. 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 15L Cycler Drainage Bag?
15L Cycler Drainage Bag is a medical device that received FDA 510(k) clearance on 2022-03-18. It is manufactured by Baxter Healthcare Corporation. The 510(k) number is K214016.
When was 15L Cycler Drainage Bag approved by the FDA?
15L Cycler Drainage Bag received FDA 510(k) clearance on 2022-03-18, under approval number K214016.
What company makes 15L Cycler Drainage Bag?
15L Cycler Drainage Bag is manufactured by Baxter Healthcare Corporation.
What is the FDA product code for 15L Cycler Drainage Bag?
The FDA product code for 15L Cycler Drainage Bag is KDJ.
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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.