Shanghai Wallaby Medical Technologies CO., Inc.

FDA Device Registration & Listing · Shanghai, CN · Registration 3014644549

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014644549
FEI Number
3014644549
Entity Name
Shanghai Wallaby Medical Technologies CO., Inc.
City/State/Country
Shanghai, CN
Establishment Address
Area C, No. 3, Lane 299, Kangwei Road, Pudong New Area, Shanghai 201315, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Wallaby Medical (Owner Number: 10058082)
Owner / Operator Contact Address
22901 Mill Creek Drive, Laguna Hills, CA 92653, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K231056
PMA Number
N/A

All Registered Proprietary Names

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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
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
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2018-07-05
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2023-12-21
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2023-12-21
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2023-03-15
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2023-03-15
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2021-12-17
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2024-03-15
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2024-03-15

Official Correspondent

No official correspondent registered.

US Agent Details

Earl Bardsley Business: Wallaby Medical Email: earl.bardsley@wallabyphenox.com Phone: (949) 4809466

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
3012543881 WALLABY MEDICAL Laguna Hills, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K033736 Concentric Medical, Inc. MERCI RETRIEVER, MODELS 90065, 90066 2004-08-11
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

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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
Z-0010-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014644549. Last updated year: 2026. Please use registration number 3014644549 when referencing this establishment in official correspondence.
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