FDA Registration
Active
🇺🇸 United States
Wahoo
Reg #: 3020954126
·
FEI: 3020954126
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Q'apel Medical, Inc.
- Registration Number
- 3020954126
- FEI Number
- 3020954126
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4245 Technology Drive
- City
- Fremont
- State
- CA
- ZIP
- 94538
- Country
- US
Regulatory Submissions
- 510(k) Number
- K181000
Owner / Operator
- Firm Name
- Q'Apel Medical Inc.
- Operator Number
- 10058467
- Address
- 4245 Technology Drive
- City
- Fremont
- State
- CA
- Postal Code
- 94538
- Country
- US
- Correspondent
- Jennifer Mateus
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2018-10-03 |
Proprietary Names
Wahoo
SelectFlex 072 Neurovascular Access System
Establishment Types
Manufacture Medical Device