Medical device licence · 98661 · Class 4
INDIGO ASPIRATION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed February 21, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 98661
- Licence holder
- Penumbra Inc.Alameda, CA, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- February 21, 2017
- Devices covered
- 49
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ASPIRATION CATHETER 12 + ASPIRATION TUBING, HTORQ
- ASPIRATION CATHETER 12 + ASPIRATION TUBING, STRAIGHT
- ASPIRATION CATHETER 12 + ASPIRATION TUBING, XTORQ
- ASPIRATION CATHETER 12 + LIGHTNING ASPIRATION TUBING HTORQ
- ASPIRATION CATHETER 12 + LIGHTNING ASPIRATION TUBING XTORQ
- ASPIRATION CATHETER 7 + ASPIRATION TUBING, STRAIGHT
- ASPIRATION CATHETER 7 + ASPIRATION TUBING, TORQ
- ASPIRATION CATHETER 7 + ASPIRATION TUBING, XTORQ
- ASPIRATION CATHETER 7 + LIGHTNING ASPIRATION TUBING, XTORQ
- ASPIRATION CATHETER 7D + ASPIRATION TUBING, XTORQ
- ASPIRATION CATHETER 8, STRAIGHT
- ASPIRATION CATHETER 8, STRAIGHT, LIGHTNING ASPIRATION TUBING
- ASPIRATION CATHETER 8, TORQ
- ASPIRATION CATHETER 8, TORQ, LIGHTNING ASPIRATION TUBING
- ASPIRATION CATHETER 8, XTORQ
- ASPIRATION CATHETER 8, XTORQ, LIGHTNING ASPIRATION TUBING
- ASPIRATION CATHETER D, STRAIGHT, LIGHTNING ASPIRATION TUBING
- CAT 6X ASPIRATION CATHETER
- CAT 6X ASPIRATION CATHETER + ASPIRATION TUBING
- CAT 6X ASPIRATION CATHETER + TRAX + ASPIRATION TUBING
- CAT 6X ASPIRATION CATHETER STRAIGHT TIP + LIGHTNING BOLT ASPIRATION TUBING
- CAT 6X ASPIRATION CATHETER STRAIGHT TIP + TRAX + LIGHTNING BOLT ASPIRATION TUBING
- CAT12 ASPIRATION CATHETER LIGHTNING BOLT ASPIRATION TUBING
- CAT3 ASPIRATION CATHETER LIGHTNING BOLT ASPIRATION TUBING
- CAT5 ASPIRATION CATHETER LIGHTNING BOLT ASPIRATION TUBING
- CAT6 ASPIRATION CATHETER LIGHTNING BOLT ASPIRATION TUBING
- CAT7 ASPIRATION CATHETER LIGHTNING BOLT ASPIRATION TUBING
- CAT7D ASPIRATION CATHETER LIGHTNING BOLT ASPIRATION TUBING
- CAT8 ASPIRATION CATHETER LIGHTNING BOLT ASPIRATION TUBING
- CATD ASPIRATION CATHETER LIGHTNING BOLT ASPIRATION TUBING
- INDIGO SYSTEM ASPIRATION CATHETER
- INDIGO SYSTEM ASPIRATION CATHETER + ASPIRATION TUBING
- INDIGO SYSTEM ASPIRATION CATHETER D
- INDIGO SYSTEM ASPIRATION TUBING
- INDIGO SYSTEM CAT RX ASPIRATION CATHETER + ASPIRATION TUBING
- INDIGO SYSTEM INHALE ASPIRATION CATHETER
- INDIGO SYSTEM LIGHTNING FLASH FLASH ASPIRATION CATHETER, HTORQ TIP + LIGHTNING FLASH ASPIRATION TUBING
- INDIGO SYSTEM LIGHTNING FLASH FLASH ASPIRATION CATHETER, STRAIGHT TIP + LIGHTNING FLASH ASPIRATION TUBING
- INDIGO SYSTEM LIGHTNING FLASH FLASH ASPIRATION CATHETER, XTORQ TIP + LIGHTNING FLASH ASPIRATION TUBING
- INDIGO SYSTEM NON-STERILE PUMP MAX SUPPLIES
- INDIGO SYSTEM SEPARATOR
- INDIGO SYSTEM SEPARATOR 4
- LIGHTNING BOLT 7 CAT 7 ASPIRATION CATHETER STRAIGHT TIP + LIGHTNING BOLT ASPIRATION TUBING
- LIGHTNING BOLT 7 CAT 7 ASPIRATION CATHETER TORQ TIP + LIGHTNING BOLT ASPIRATION TUBING
- LIGHTNING BOLT 7 CAT 7 ASPIRATION CATHETER XTORQ TIP + LIGHTNING BOLT ASPIRATION TUBING
- PENUMBRA PUMP MAX
- SEPARATOR 12
- SEPARATOR 7
- SEPARATOR 7D
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.