FDA Registration
Active
🇨🇳 China
Shanghai Wallaby Medical Technologies CO., Inc.
Reg #: 3014644549
·
FEI: 3014644549
·
Expires 2026
Products
5
Proprietary Names
7
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- Shanghai Wallaby Medical Technologies CO., Inc.
- Registration Number
- 3014644549
- FEI Number
- 3014644549
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Area C, No. 3, Lane 299, Kangwei Road, Pudong New Area
- City
- Shanghai
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K240917
Owner / Operator
- Firm Name
- Wallaby Medical
- Operator Number
- 10058082
- Address
- 22901 Mill Creek Drive
- City
- Laguna Hills
- State
- CA
- Postal Code
- 92653
- Country
- US
US Agent
- Business Name
- Wallaby Medical
- Contact Name
- Earl Bardsley
- Address
- 22901 MILL CREEK DRIVE
- City
- Laguna Hills
- State
- CA
- ZIP
- 92653
- Country
- US
- [email protected]
- Phone
- 949 4809466
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Thrombus Retriever | NRY | Class 2 | Cardiovascular | No | 2024-11-07 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2023-05-17 |
| Catheter, Percutaneous, Neurovasculature | QJP | Class 2 | Cardiovascular | No | 2023-05-17 |
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2023-05-17 |
| Device, Neurovascular Embolization | HCG | Class 2 | Neurology | No | 2018-07-05 |
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
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)