FDA Registration
Active
🇺🇸 United States
Advisor HD Grid Sensor Enabled, High Density Mapping Catheter
Reg #: 2030404
·
FEI: 1000519796
·
Expires 2025
Products
4
Proprietary Names
6
Establishment Types
2
Classifications
4
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
Regulatory Submissions
- 510(k) Number
- K251211
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 |
|---|---|---|---|---|---|
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2025-07-01 |
| Catheter, Ultrasound, Intravascular | OBJ | Class 2 | Cardiovascular | No | 2025-07-01 |
| Reprocessed Intravascular Ultrasound Catheter | OWQ | Class 2 | Cardiovascular | No | 2025-07-01 |
| Catheter, Intracardiac Mapping, High-Density Array | MTD | Class 2 | Cardiovascular | No | 2025-07-01 |
Proprietary Names
Advisor HD Grid Sensor Enabled, High Density Mapping Catheter
Advisor HD Grid X, Sensor Enabled, High Density Mapping Catheter
Agilis NxT, Steerable Introducer
Agilis NxT Steerable Introducer Dual Reach, Steerable Introducer
ViewFlex Xtra, ICE Catheter
ViewFlex Eco, Reprocessed ICE Catheter
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility