FDA Registration
Active
🇺🇸 United States
Pounce Sheath
Reg #: 3016986313
·
FEI: 3016986313
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SWITCHBACK MEDICAL
- Registration Number
- 3016986313
- FEI Number
- 3016986313
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7625 Boone Avenue N
- City
- Brooklyn Park
- State
- MN
- ZIP
- 55428
- Country
- US
Regulatory Submissions
- 510(k) Number
- K231828
Owner / Operator
- Firm Name
- Switchback Medical
- Operator Number
- 10075207
- Address
- 7625 Boone Avenue N
- City
- Brooklyn Park
- State
- MN
- Postal Code
- 55428
- Country
- US
- Correspondent
- Barbara Beiersdorf
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2023-10-04 |
Proprietary Names
Pounce Sheath
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)