6F Wallaby Long Sheath
K-Number: K222603 · 2023-03-02
ApplicantWallaby Medical, Inc.
Decision Date2023-03-02
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
6F Wallaby Long Sheath is a medical device manufactured by Wallaby Medical, Inc.. It received FDA 510(k) clearance on 2023-03-02 under approval number K222603. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the 6F Wallaby Long Sheath?
6F Wallaby Long Sheath is a medical device that received FDA 510(k) clearance on 2023-03-02. It is manufactured by Wallaby Medical, Inc.. The 510(k) number is K222603.
When was 6F Wallaby Long Sheath approved by the FDA?
6F Wallaby Long Sheath received FDA 510(k) clearance on 2023-03-02, under approval number K222603.
What company makes 6F Wallaby Long Sheath?
6F Wallaby Long Sheath is manufactured by Wallaby Medical, Inc..
What is the FDA product code for 6F Wallaby Long Sheath?
The FDA product code for 6F Wallaby Long Sheath is DQY.
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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.