Medical device licence · 9569 · Class 2
STATLOCK CATHETER SECUREMENT DEVICE
Yes: licensed in Canada
Licence status Issued (active); first licensed August 10, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 9569
- Licence holder
- Bard Access Systems, Inc.Salt Lake City, UT, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- August 10, 1999
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- STATLOCK - ARTERIAL
- STATLOCK - EPIDURAL
- STATLOCK - EXTENSION SET
- STATLOCK - IV
- STATLOCK IV SELECT STABLIZATION DEVICE
- STATLOCK STABILIZATION DEVICE (IV SELECT) WITH EXTENSION SET
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 “statlock”. A notice may cover another product or only some lots: read it to see what it covers.
- StatLock CV Plus Stabilization DeviceJanuary 12, 2017 · Medical devices · Type II
- Statlock Arterial Ultra DeviceSeptember 3, 2012 · Medical devices · Labelling · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.