FDA Registration
Active
🇺🇸 United States
Inquiry AFocus II Diagnostic Catheter
Reg #: 2030404
·
FEI: 1000519796
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- IRVINE BIOMEDICAL. INC.
- Registration Number
- 2030404
- FEI Number
- 1000519796
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2375 Morse Ave
- City
- IRVINE
- State
- CA
- ZIP
- 92614
- Country
- US
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 |
|---|---|---|---|---|---|
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | Class 2 | Cardiovascular | No | 2020-03-24 |
Proprietary Names
Inquiry AFocus II Diagnostic Catheter
Inquiry Cardioversion Fixed Curve Diagnostic Catheter
Inquiry Luma-Cath Fixed Curve Diagnostic Catheter
Inquiry Luma-Cath Steerable Diagnostic Catheter
Inquiry Fixed Curve Diagnostic Catheter
Inquiry Optima Diagnostic Catheter
Inquiry Steerable Diagnostic Catheter
Establishment Types
Manufacture Device in the United States for Export Only