Medical device licence · 8197 · Class 2
PERCUTANEOUS INTRODUCER SETS
Yes: licensed in Canada
Licence status Issued (active); first licensed July 16, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 8197
- 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
- July 16, 1999
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- GROSHONG CV CATHETER PERCUTANEOUS INTRODUCER KIT
- MICROINTRODUCER KIT
- PEEL APART PERCUTANEOUS INTRODUCER KIT
- PER-Q-CATH EXCALIBUR INTRODUCER
- PERCUTANEOUS INTRODUCER SYSTEM
- RADSTIC RADIOLOGY MICROINTRODUCER KIT
- SAFETY MI PERCUTANEOUS INTRODUCER KIT
- SAFETY MI PERCUTANEOUS INTRODUCER KIT WITH NITINOL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.