FDA Registration
Active
🇺🇸 United States
WALLABY MEDICAL
Reg #: 3012543881
·
FEI: 3012543881
·
Expires 2026
Products
5
Proprietary Names
7
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- WALLABY MEDICAL
- Registration Number
- 3012543881
- FEI Number
- 3012543881
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 22901 Mill Creek Drive
- City
- Laguna Hills
- State
- CA
- ZIP
- 92653
- Country
- US
Regulatory Submissions
- 510(k) Number
- K222603
Owner / Operator
- Firm Name
- Wallaby Medical
- Operator Number
- 10058082
- Address
- 22901 Mill Creek Drive
- City
- Laguna Hills
- State
- CA
- Postal Code
- 92653
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Percutaneous, Neurovasculature | QJP | Class 2 | Cardiovascular | No | 2023-03-15 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2023-03-15 |
| Catheter, Thrombus Retriever | NRY | Class 2 | Cardiovascular | No | 2021-12-17 |
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2023-05-17 |
| Device, Neurovascular Embolization | HCG | Class 2 | Neurology | No | 2018-07-05 |
Proprietary Names
Pilote Long Sheath
Esperance Distal Access Catheter
Esperance Aspiration Catheter System
Esperance 3+ Aspiration Catheter System
pNOVUS 17
Paragon 8F Balloon Guide Catheter
Wallaby Avenir Coil System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility