FDA Registration
Active
🇺🇸 United States
Abbott Medical
Reg #: 3009600098
·
FEI: 3009600098
·
Expires 2026
Products
8
Proprietary Names
37
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- Abbott Medical
- Registration Number
- 3009600098
- FEI Number
- 3009600098
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4 Robbins Rd
- City
- Westford
- State
- MA
- ZIP
- 01886
- Country
- US
Regulatory Submissions
- 510(k) Number
- K150237
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, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2017-05-18 |
| System, Imaging, Optical Coherence Tomography (Oct) | NQQ | Class 2 | Radiology | No | 2017-05-18 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2021-06-08 |
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2021-06-08 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2019-04-02 |
| Transducer, Pressure, Catheter Tip | DXO | Class 2 | Cardiovascular | No | 2018-06-28 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2018-06-28 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2018-06-28 |
Proprietary Names
ILUMIEN System and Accessories with Dragonfly OPTIS Imaging Catheter
Dragonfly OPTIS Imaging Catheter Kit
OPTIS Mobile Next
Optis Tableside Controller Next
Optis Integrated Next
Optis Mobile Next Imaging System
Optis Integrated Pre-Install Kit
Optis Mobile Next Direct Upgrade Accessory Kit
Optis Next Upgrade Kit
Ultreon 2 Software Upgrade Kit
Ultiri Measurement System
OPTIS Mobile System and Accessories
ILUMIEN Systems with AptiVue Software Version D.3
ILUMIEN OPTIS Mobile System
ILUMIEN OPTIS Mobile System Accessories
RadiAnalyzer Xpress Monitor Cable 12900 Series
Quantien Measurement System
Quantien Mounting Stands and Brackets
Quantien Measurement System Monitor Cables C12900 Series
RadiAnalyzer Xpress Cable Converter C12784
Quantien Measurement System Adapter C12600 series
Quantien Measurement System AUX OUT Cable C12796
Quantien Measurement System C12787
RadiAnalyzer Adapter Cables 12600 series
Quantien Measurement System AUX IN Cable C12500-C12510
ILUMIEN OPTIS, OPTIS Integrated, OPTIS Mobile with AptiVue Software version E.5.2
ILUMIEN OPTIS System
AptiVue Imaging Software version E.6
OPTIS Integrated System
OPTIS Mobile System
PressureWire X
OPTIS Integrated System and Accessories
OPTIS Mobile Next Imaging System
Ultreon 3 Software Upgrade Kit
OPTIS Integrated Next Imaging System
Dragonfly OpStar Imaging Catheter.
E.4 Metallis Stent Optimization E.4 SW
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility