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FDA 510(k)

p17 XR Microcatheter

K-Number: K254071 · 2026-08-18

ApplicantWallaby Medical
Decision Date2026-08-18
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

p17 XR Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is Wallaby Medical. It received FDA 510(k) clearance on 2026-08-18 under 510(k) number K254071. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the p17 XR Microcatheter?

p17 XR Microcatheter is a medical device that received FDA 510(k) clearance on 2026-08-18. The listed applicant is Wallaby Medical. The 510(k) number is K254071.

When did p17 XR Microcatheter receive FDA 510(k) clearance?

p17 XR Microcatheter received FDA 510(k) clearance on 2026-08-18, under 510(k) number K254071.

Who is the listed applicant for p17 XR Microcatheter?

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

What is the FDA product code for p17 XR Microcatheter?

The FDA product code for p17 XR Microcatheter is QJP.

Other records listing Wallaby Medical as applicant

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.

K240917Esperance 3+ Aspiration Catheter SystemK231056Esperance Distal Access CatheterK232437Paragon 8F Balloon Guide CatheterK223139Wallaby 017 Micro CatheterK2226036F Wallaby Long SheathK211697Esperance Aspiration Catheter System

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Related Devices (Code: QJP)

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.

K261176Zoom 4S CatheterImperative Care, Inc.K260199SLIM MicrocatheterBalt USA, LLCK253901Millipede88 Access CatheterPerfuze, Ltd.K261889Trevo Trak 21 MicrocatheterStryker NeurovascularK261808ISAAC Neurovascular Navigation CatheterMicrovention Inc. d/b/a Terumo NeuroK261549BOBBY Balloon Guide CatheterMicroVention, Inc., d/b/a Terumo Neuro

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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