Medical device licence · 94844 · Class 4
HEARTWARE VENTRICULAR ASSIST SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed March 17, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 94844
- Licence holder
- Heartware, Inc.Mounds View, MN, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- March 17, 2015
- Devices covered
- 17
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- HEARTWARE CONTROLLER DC ADAPTER
- HEARTWARE DATA CABLE
- HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY CHARGER AC ADAPTER
- HEARTWARE VENTRICULAR ASSIST SYSTEM - DRIVELINE EXTENSION CABLE
- HEARTWARE VENTRICULAR ASSIST SYSTEM - HEARTWARE BATTERY
- HEARTWARE VENTRICULAR ASSIST SYSTEM - HEARTWARE BATTERY CHARGER
- HEARTWARE VENTRICULAR ASSIST SYSTEM - HEARTWARE CONTROLLER
- HEARTWARE VENTRICULAR ASSIST SYSTEM - HEARTWARE CONTROLLER AC ADAPTER
- HEARTWARE VENTRICULAR ASSIST SYSTEM - HEARTWARE MONITOR
- HEARTWARE VENTRICULAR ASSIST SYSTEM - HEARTWARE MONITOR AC ADAPTER
- HEARTWARE VENTRICULAR ASSIST SYSTEM - HVAD IMPLANT KIT
- HEARTWARE VENTRICULAR ASSIST SYSTEM - IMPLANT ACCESSORIES KIT
- HEARTWARE VENTRICULAR ASSIST SYSTEM - OUTFLOW GRAFT
- HEARTWARE VENTRICULAR ASSIST SYSTEM - STERILE SURGICAL TOOL KIT
- HVAD ALARM ADAPTER
- HVAD CONTROLLER
- HVAD PUMP SURGICAL TOOLS - EXTENDED LENGTH
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.