FDA Registration
Active
🇺🇸 United States
RX Herculink Elite Renal Stent System
Reg #: 2024168
·
FEI: 2024168
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ABBOTT VASCULAR
- Registration Number
- 2024168
- FEI Number
- 2024168
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 26531 YNEZ RD.
- City
- Temecula
- State
- CA
- ZIP
- 92591
- Country
- US
Regulatory Submissions
- PMA Number
- P110001
Owner / Operator
- Firm Name
- ABBOTT LABORATORIES
- Operator Number
- 1415939
- Address
- 100 ABBOTT PARK RD., D-03Q3, AP52-1
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stent, Renal | NIN | Class 3 | Unknown | No | 2012-09-07 |
Proprietary Names
RX Herculink Elite Renal Stent System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device