Data / Medical devices / United States / Amphenol DC Electronics
Amphenol DC Electronics: FDA-registered device maker in San Jose, CA, United States, 1 510(k) clearance
Amphenol DC Electronics is registered with the FDA (registration 3001763079) in San Jose, CA, United States. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 6, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3001763079
- Address
- 1870 Little Orchard St, San Jose, CA, United States, 95125
- Owner or operator
- Amphenol DC Electronics (10043592)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- March 1, 2013
- Registered through
- 2026
- Brand names listed
- HeartMate II, Hemodynamic Cable Kits, Non-Sterile Cable (Controller to Pump or Remote Control)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cardiac Ablation Percutaneous Catheter | LPB | 3 | Contract manufacturer | accessdata.fda.gov |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | OAD | 3 | Contract manufacturer | accessdata.fda.gov |
| Charger, Pacemaker | KRF | 1 | Manufacturer | accessdata.fda.gov |
| Computer, Blood-Pressure | DSK | 2 | Manufacturer | accessdata.fda.gov |
| Computer, Diagnostic, Programmable | DQK | 2 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 6, 2015 | K151613 | iLab Polaris Multi-Modality Guidance System | DQK | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Computer, Diagnostic, Programmable
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of Computer, Blood-Pressure
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Cardiac Ablation Percutaneous Catheter
- All makers of Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Updated October 6, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.