Data / Medical devices / United States / Wallaby Medical

Wallaby Medical: FDA-registered device maker in Laguna Hills, CA, United States, 8 510(k) clearances

Name: Wallaby Medical FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Wallaby Medical is registered with the FDA (registration 3012543881) in Laguna Hills, CA, United States. It lists 5 device types. The FDA files 8 510(k) clearances under its listings, the newest dated August 18, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012543881
Address: 22901 Mill Creek Drive, Laguna Hills, CA, United States, 92653
Owner or operator: Wallaby Medical (10058082)
Roles: Specification developer
First device listed: July 5, 2018
Registered through: 2026
Brand names listed: Esperance 3+ Aspiration Catheter System, Esperance Aspiration Catheter System, Esperance Distal Access Catheter, Paragon 8F Balloon Guide Catheter, Pilote Long Sheath, Wallaby Avenir Coil System, p17 XR Microcatheter, pNOVUS 17

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Continuous Flush	KRA	2	Specification developer	accessdata.fda.gov
Catheter, Percutaneous	DQY	2	Specification developer	accessdata.fda.gov
Catheter, Percutaneous, Neurovasculature	QJP	2	Specification developer	accessdata.fda.gov
Catheter, Thrombus Retriever	NRY	2	Specification developer	accessdata.fda.gov
Device, Neurovascular Embolization	HCG	2	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 18, 2026	K254071	p17 XR Microcatheter	QJP	Substantially Equivalent	Wallaby Medical	accessdata.fda.gov
October 1, 2024	K240917	Esperance 3+ Aspiration Catheter System	NRY	Substantially Equivalent	Wallaby Medical	accessdata.fda.gov
March 8, 2024	K231056	Esperance Distal Access Catheter	QJP	Substantially Equivalent	Wallaby Medical	accessdata.fda.gov
October 13, 2023	K232437	Paragon 8F Balloon Guide Catheter	DQY	Substantially Equivalent	Wallaby Medical	accessdata.fda.gov
April 25, 2023	K223139	Wallaby 017 Micro Catheter	KRA	Substantially Equivalent	Wallaby Medical	accessdata.fda.gov
March 2, 2023	K222603	6F Wallaby Long Sheath	DQY	Substantially Equivalent	Wallaby Medical, Inc.	accessdata.fda.gov
November 16, 2021	K211697	Esperance Aspiration Catheter System	NRY	Substantially Equivalent	Wallaby Medical	accessdata.fda.gov
May 4, 2018	K173711	Wallaby Avenir Coil System	HCG	Substantially Equivalent	Wallaby Medical, Inc.	accessdata.fda.gov

Compare with other makers

Updated August 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.