FDA 510(k)

Wallaby 017 Micro Catheter

K-Number: K223139 · 2023-04-25

Decision Date2023-04-25

Product CodeKRA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Wallaby 017 Micro Catheter is a medical device manufactured by Wallaby Medical. It received FDA 510(k) clearance on 2023-04-25 under approval number K223139. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Wallaby 017 Micro Catheter?

Wallaby 017 Micro Catheter is a medical device that received FDA 510(k) clearance on 2023-04-25. It is manufactured by Wallaby Medical. The 510(k) number is K223139.

When was Wallaby 017 Micro Catheter approved by the FDA?

Wallaby 017 Micro Catheter received FDA 510(k) clearance on 2023-04-25, under approval number K223139.

What company makes Wallaby 017 Micro Catheter?

Wallaby 017 Micro Catheter is manufactured by Wallaby Medical.

What is the FDA product code for Wallaby 017 Micro Catheter?

The FDA product code for Wallaby 017 Micro Catheter is KRA.

Related Clinical Trials

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Related Devices (Code: KRA)

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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.