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FDA 510(k)

Hudson RCI Comfort Flo® CubCannula™

K-Number: K241778 · 2024-12-19

Decision Date2024-12-19
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Hudson RCI Comfort Flo® CubCannula™ is a medical device manufactured by Medline Industries, LP. It received FDA 510(k) clearance on 2024-12-19 under approval number K241778. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hudson RCI Comfort Flo® CubCannula™?

Hudson RCI Comfort Flo® CubCannula™ is a medical device that received FDA 510(k) clearance on 2024-12-19. It is manufactured by Medline Industries, LP. The 510(k) number is K241778.

When was Hudson RCI Comfort Flo® CubCannula™ approved by the FDA?

Hudson RCI Comfort Flo® CubCannula™ received FDA 510(k) clearance on 2024-12-19, under approval number K241778.

What company makes Hudson RCI Comfort Flo® CubCannula™?

Hudson RCI Comfort Flo® CubCannula™ is manufactured by Medline Industries, LP.

What is the FDA product code for Hudson RCI Comfort Flo® CubCannula™?

The FDA product code for Hudson RCI Comfort Flo® CubCannula™ is BTT.

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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.