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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2022-03-18 under 510(k) 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. The listed applicant is Baxter Healthcare Corporation. The 510(k) number is K214016.

When did 15L Cycler Drainage Bag receive FDA 510(k) clearance?

15L Cycler Drainage Bag received FDA 510(k) clearance on 2022-03-18, under 510(k) number K214016.

Who is the listed applicant for 15L Cycler Drainage Bag?

The FDA 510(k) record lists Baxter Healthcare Corporation as the applicant. This does not by itself establish the device manufacturer.

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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Related Devices (Code: KDJ)

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.

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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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