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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Wallaby Medical, Inc.. It received FDA 510(k) clearance on 2023-03-02 under 510(k) 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. The listed applicant is Wallaby Medical, Inc.. The 510(k) number is K222603.

When did 6F Wallaby Long Sheath receive FDA 510(k) clearance?

6F Wallaby Long Sheath received FDA 510(k) clearance on 2023-03-02, under 510(k) number K222603.

Who is the listed applicant for 6F Wallaby Long Sheath?

The FDA 510(k) record lists Wallaby Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 6F Wallaby Long Sheath?

The FDA product code for 6F Wallaby Long Sheath is DQY.

Other records listing Wallaby Medical, Inc. as applicant

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Related Devices (Code: DQY)

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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