FDA Registration
Active
🇺🇸 United States
Boston Scientific Cardiac Diagnostic Technologies, Inc.
Reg #: 3022298579
·
FEI: 3022298579
·
Expires 2026
Products
4
Proprietary Names
0
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- Boston Scientific Cardiac Diagnostic Technologies, Inc.
- Registration Number
- 3022298579
- FEI Number
- 3022298579
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1150 Cummings Park Drive
- City
- Arden Hills
- State
- MN
- ZIP
- 55112
- Country
- US
Regulatory Submissions
- 510(k) Number
- K243349
Owner / Operator
- Firm Name
- Boston Scientific Corporation
- Operator Number
- 9912058
- Address
- 300 Boston Scientific Way
- City
- Marlborough
- State
- MA
- Postal Code
- 01752
- Country
- US
- Correspondent
- Adrienne Bishop
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Electrocardiograph, Multi-Function | MLN | Class 2 | Cardiovascular | No | 2021-10-28 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2021-10-28 |
| Outpatient Cardiac Telemetry | QYX | Class 2 | Cardiovascular | No | 2026-03-20 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2026-03-20 |
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device