Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012543881

FEI Number

3012543881

Entity Name

WALLABY MEDICAL

City/State/Country

Laguna Hills, CA, US

Establishment Address

22901 Mill Creek Drive, Laguna Hills, CA 92653, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Wallaby Medical (Owner Number: 10058082)

Owner / Operator Contact Address

22901 Mill Creek Drive, Laguna Hills, CA 92653, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K232437

PMA Number

N/A

All Registered Proprietary Names

Pilote Long Sheath Esperance Distal Access Catheter Esperance Aspiration Catheter System Esperance 3+ Aspiration Catheter System pNOVUS 17 Paragon 8F Balloon Guide Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2023-03-15
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2023-03-15
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2024-03-15
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2024-03-15
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2021-12-17
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2024-11-07
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2023-05-17
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2023-05-17
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2023-05-17
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2023-12-21
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2023-12-21

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Wallaby Medical

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014644549	Shanghai Wallaby Medical Technologies CO., Inc.	Shanghai, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K043580	Chestnut Medical Technologies, Inc.	ALLIGATOR RETRIEVAL DEVICE (ARD)	2005-03-24
K982883	Medtronics Interventional Vascular	MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER	1998-09-04
K132420	Reflow Medical	WINGMAN EXTENDABLE TIP SUPPORT CATHETER	2013-09-19
K082339	Endocross, Ltd.	ENABLER-P SUPPORT CATHETER	2008-11-20
K210009	CenterPoint Systems, LLC	Guiding Catheter	2021-11-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2025	Stryker Neurovascular	2	The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 100cm to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization. A rotating hemostatic valve with side-arm adapter is provided with each microcatheter.
Z-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-04	Bard Peripheral Vascular	2	Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124

Similar Registrations

Registration Number	Establishment Name	Location
3031768596	PIRAEUS MEDICAL, INC.	Maple Grove, MN, US
3031311812	TORO NEUROVASCULAR, INC.	Irvine, CA, US
3016800412	ICS MEDICAL DEVICES LTD	Galway Galway (City), IE
3012931345	Stryker Neurovascular	Salt Lake City, UT, US
3003775027	ASAHI INTECC CO., LTD.	SETO Aichi, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012543881. Last updated year: 2026. Please use registration number 3012543881 when referencing this establishment in official correspondence.