Medical device licence · 7488 · Class 4
GELWEAVE VASCULAR PROSTHESIS
Yes: licensed in Canada
Licence status Issued (active); first licensed July 14, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 7488
- Licence holder
- Vascutek LimitedInchinnan, United Kingdom
- Risk class
- Class IV (highest risk)
- Licence type
- Device Family
- First licensed
- July 14, 1999
- Devices covered
- 55
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- GELWEAVE BAVARIA ZONE 2
- GELWEAVE ANTE-FLO
- GELWEAVE ANTE-FLO OFFSET PRE-CURVED
- GELWEAVE ANTE-FLO PRE-CURVED
- GELWEAVE ANTE-FLO RADIOPAQUE
- GELWEAVE ANTE-FLO XL OFFSET
- GELWEAVE ANTE-FLO XL PRE-CURVED
- GELWEAVE ARCH GRAFT
- GELWEAVE BAVARIA ZONE 2 SIENA
- GELWEAVE BIFURCATE
- GELWEAVE BRANCHED ARCH
- GELWEAVE COSELLI THORACOABDOMINAL
- GELWEAVE CURVED SIENA PLEXUS RADIOPAQUE
- GELWEAVE DOUBLE BIFURCATE
- GELWEAVE DOUBLE BIFURCATE RADIOPAQUE
- GELWEAVE DOUBLE BIFURCATE SIDE BRANCH RADIOPAQUE
- GELWEAVE LUPIAE ARCH
- GELWEAVE PLEXUS
- GELWEAVE PRE-CURVED
- GELWEAVE PRE-CURVED PLEXUS
- GELWEAVE RADIAL PLEXUS
- GELWEAVE SIENA ANTE-FLO
- GELWEAVE SIENA ANTE-FLO PRE-CURVED RADIOPAQUE
- GELWEAVE SIENA COLLARED 4 BRANCH PLEXUS WITH RADIOPAQUE MARKERS
- GELWEAVE SIENA COLLARED ANTE-FLO WITH RADIOPAQUE MARKERS
- GELWEAVE SIENA PLEXUS
- GELWEAVE SIENA STRAIGHT
- GELWEAVE STRAIGHT
- GELWEAVE STRAIGHT 3 BLACK LINE
- GELWEAVE THORACIC ARCH
- GELWEAVE THORACIC ARCH RADIOPAQUE
- GELWEAVE THORACOABDOMINAL
- GELWEAVE THORACOABDOMINAL GRAFT
- GELWEAVE TRIFURCATE
- GELWEAVE TRIFURCATE ARCH
- GELWEAVE TRIFURCATE ARCH SIDE BRANCH
- GELWEAVE TRIFURCATE ARCH SIDE BRANCH RADIOPAQUE
- GELWEAVE TRIFURCATE SIDE BRANCH
- GELWEAVE VALSALVA
- GELWEAVE VALSALVA (LONG)
- GELWEAVE VALSALVA (NARROW)
- GELWEAVE VALSALVA (SHORT)
- GELWEAVE VALSALVA ANTE-FLO
- GELWEAVE VALSALVA ANTE-FLO (SHORT)
- GELWEAVE VALSALVA FLORIDA SLEEVE
- GELWEAVE VALSALVA WITH COLLAR
- GELWEAVE W ARCH
- TRIFURCATE GRAFT
- VASCUTEK GELWEAVE ANTE-FLO VASCULAR PROSTHESIS
- VASCUTEK GELWEAVE ANTE-FLO WITH COLLAR VASCULAR PROSTHESIS
- VASCUTEK GELWEAVE PLEXUS 3- BRANCH VASCULAR PROSTHESIS
- VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS
- VASCUTEK GELWEAVE VASCULAR PROSTHESIS - BIFURCATE
- VASCUTEK GELWEAVE VASCULAR PROSTHESIS - STRAIGHT
- VASCUTEK GELWEAVE VASCULAR PROSTHESIS WITH SIDE BRANCH
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 “gelweave”. A notice may cover another product or only some lots: read it to see what it covers.
- Vascuteks' various Gelweave, ePTFE, SEALPTFE, Thin Wall Fluoropassiv, Gelsoft ERS, Gelsoft Plus, Gelsoft Plus ERS and GelsealERT Vascular Prosthesis (2017-12-13)January 12, 2018 · Medical devices · Medical devices · Type III
- Variuos Instruments from Gelweave Vascular Prosthesis (2014-07-08)August 1, 2014 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.