Medical device licence · 93596 · Class 4
PENUMBRA SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 21, 2014. It is in Health Canada’s list of active licences.
- Licence number
- 93596
- Licence holder
- Penumbra Inc.Alameda, CA, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- July 21, 2014
- Devices covered
- 41
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 3D REVASCULARIZATION DEVICE
- ASPIRATION PUMP
- ASPIRATION TUBING
- MAX ASPIRATION TUBING
- NON-STERILE PUMP SUPPLIES
- PENUMBRA SYSTEM - REPERFUSION CATHETER 3MAX - KIT
- PENUMBRA SYSTEM - REPERFUSION CATHETER 4MAX MP SHAPE KIT
- PENUMBRA SYSTEM - REPERFUSION CATHETER 4MAX STRAIGHT KIT
- PENUMBRA SYSTEM - REPERFUSION CATHETER 5MAX KIT
- PENUMBRA SYSTEM - REPERFUSION CATHETER ACE 60
- PENUMBRA SYSTEM - REPERFUSION CATHETER ACE 60 KIT
- PENUMBRA SYSTEM - REPERFUSION CATHETER ACE 64
- PENUMBRA SYSTEM - REPERFUSION CATHETER ACE 64 KIT
- PENUMBRA SYSTEM - REPERFUSION CATHETER ACE 68
- PENUMBRA SYSTEM - REPERFUSION CATHETER ACE 68 KIT
- PENUMBRA SYSTEM MAX - REPERFUSION CATHETER 3MAX
- PENUMBRA SYSTEM MAX - REPERFUSION CATHETER 4MAX
- PENUMBRA SYSTEM MAX - REPERFUSION CATHETER 5MAX
- PENUMBRA SYSTEM MAX - REPERFUSION CATHETER 5MAX ACE
- PENUMBRA SYSTEM MAX - SEPARATOR
- RED 62 KIT
- RED 62 REPERFUSION CATHETER
- RED 68 KIT
- RED 68 REPERFUSION CATHETER
- RED 72 KIT
- RED 72 REPERFUSION CATHETER
- RED78 KIT REPERFUSION CATHETER + PENUMBRA ASPIRATION TUBING
- RED78 REPERFUSION CATHETER
- REPERFUSION CATHETER
- REPERFUSION CATHETER 3MAX
- REPERFUSION CATHETER 3MAX KIT
- REPERFUSION CATHETER JET 7 STANDARD TIP
- REPERFUSION CATHETER JET 7 STANDARD TIP KIT
- REPERFUSION CATHETER JET D
- REPERFUSION CATHETER JET D KIT
- REPERFUSION CATHETER KIT
- REPERFUSION CATHETER RED 43
- REPERFUSION CATHETER RED 43 KIT
- REPERFUSION CATHETER RED 72 SENDIT TECHNOLOGY KIT
- SEPARATOR
- SEPARATOR FLEX
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.