Medical device licence · 113322 · Class 2
FLEXOR INTRODUCERS & GUIDING SHEATHS
Yes: licensed in Canada
Licence status Issued (active); first licensed May 14, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 113322
- Licence holder
- Cook, IncorporatedBloomington, IN, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- May 14, 2025
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FLEXOR ANSEL GUIDING SHEATH
- FLEXOR CHECK-FLO II INTRODUCER SET
- FLEXOR CHECK-FLO INTRODUCER - ANSEL 1 MODIFICATION - WITH HIGH-FLEX DILATOR AND HYDROPHILIC COATING
- FLEXOR CHECK-FLO INTRODUCER - ANSEL MODIFICATION
- FLEXOR CHECK-FLO INTRODUCER - ANSEL MODIFICATION - WITH HIGHFLEX DILATOR AND HYDROPHILIC COATING
- FLEXOR CHECK-FLO INTRODUCER - BALKIN UP & OVER CONTRALATERAL DESIGN
- FLEXOR CHECK-FLO INTRODUCER - RAABE MODIFICATION
- FLEXOR CHECK-FLO INTRODUCER SET
- FLEXOR SHUTTLE - SL INTRODUCER WITH TUOHY-BORST SIDEARM
- FLEXOR TUOHY-BORST SIDE-ARM INTRODUCER - SHUTTLE-SL
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “flexor”. A notice may cover another product or only some lots: read it to see what it covers.
- Flexor® Check-Flo Introducer and Rösch-Uchida Transjugular Liver Access SetsDecember 3, 2025 · Cardiovascular - General and plastic surgery · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.