FDA Registration
Active
🇺🇸 United States
BioFlo PICC wth ENDEXO Technology
Reg #: 1319211
·
FEI: 1319211
·
Expires 2025
Products
1
Proprietary Names
6
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
- K152409
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 | 2016-09-07 |
Proprietary Names
BioFlo PICC wth ENDEXO Technology
BioFlo PICC wth ENDEXO and PASV Valve Technology
Xcela PICC with PASV Valve Technology
BioFlo Hybrid PICC wth ENDEXO and PASV Valve Technology
Xcela Hybrid PICC with PASV Valve Technology
Xcela Power Injectable PICC
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)