FDA Registration
Active
🇺🇸 United States
BIOFLO HYBRID PICC WITH ENDEXO AND PASV VALVE TECHNOLOGY
Reg #: 1319211
·
FEI: 1319211
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ANGIODYNAMICS, INC.
- Registration Number
- 1319211
- FEI Number
- 1319211
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 603 QUEENSBURY AVE.
- City
- Queensbury
- State
- NY
- ZIP
- 12804
- Country
- US
Regulatory Submissions
- 510(k) Number
- K150448
Owner / Operator
- Firm Name
- ANGIODYNAMICS, INC
- Operator Number
- 9028212
- Address
- 26 Forest St., --
- City
- Marlborough
- State
- MA
- Postal Code
- 01752
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | Class 2 | General Hospital | No | 2016-07-18 |
Proprietary Names
BIOFLO HYBRID PICC WITH ENDEXO AND PASV VALVE TECHNOLOGY
BIOFLO PICC WITH ENDEXO TECHNOLOGY
BIOFLO PICC WITH ENDEXO AND PASV VALVE TECHNOLOGY
XCELA POWER INJECTABLE PICC
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)