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The Tracker / August 2026 / K254071

510(k) cleared

p17 XR Microcatheter

Wallaby Medical · Aug 18, 2026 · K254071

FDA cleared the p17 XR Microcatheter from Wallaby Medical on Aug 18, 2026 under K254071, a traditional 510(k). The device falls under product code QJP, Catheter, Percutaneous, Neurovasculature, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 18, 2025. The decision came 243 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Wallaby Medical in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254071?

K254071 is the FDA 510(k) for p17 XR Microcatheter, submitted by Wallaby Medical. FDA's decision date was Aug 18, 2026, under product code QJP (Catheter, Percutaneous, Neurovasculature).

Who makes the p17 XR Microcatheter?

Wallaby Medical, based in Laguna Hills, CA, is the applicant of record for K254071.

How long did the K254071 review take?

FDA received the submission on Dec 18, 2025 and issued its decision on Aug 18, 2026, 243 days later.

← All decisions in August 2026