FDA Registration
Active
🇺🇸 United States
AMPHENOL DC ELECTRONICS
Reg #: 3001763079
·
FEI: 3001763079
·
Expires 2026
Products
7
Proprietary Names
3
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- AMPHENOL DC ELECTRONICS
- Registration Number
- 3001763079
- FEI Number
- 3001763079
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1870 Little Orchard St
- City
- San Jose
- State
- CA
- ZIP
- 95125
- Country
- US
Regulatory Submissions
- 510(k) Number
- K151613
Owner / Operator
- Firm Name
- Amphenol DC Electronics
- Operator Number
- 10043592
- Address
- 1870 Little Orchard Street
- City
- San Jose
- State
- CA
- Postal Code
- 95125
- Country
- US
- Correspondent
- Liza Gampon
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2015-10-25 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2015-10-25 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2015-10-25 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2015-10-25 |
| Charger, Pacemaker | KRF | Class 1 | Cardiovascular | No | 2013-03-01 |
| Cardiac Ablation Percutaneous Catheter | LPB | Class 3 | Unknown | No | 2021-06-14 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | OAD | Class 3 | Unknown | No | 2021-06-14 |
Proprietary Names
Hemodynamic Cable Kits
HeartMate II
Non-Sterile Cable (Controller to Pump or Remote Control)
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)