ApprovalTrail

Medical device licence · 247 · Class 2

PERCUTANEOUS SHEATH INTRODUCER SETS

Yes: licensed in Canada

Licence status Issued (active); first licensed December 8, 1998. It is in Health Canada’s list of active licences.
Licence number
247
Licence holder
Arrow International Llc Subsidiary Of Teleflex IncorporatedMorrisville, NC, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Group Family
First licensed
December 8, 1998
Devices covered
10

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • ARROW CRITICAL CARE POLY PERCUT SHEATH INTRO SETS FOR CENTRAL VENOUS ACCESS
  • ARROW-FLEX POLY PERCUT SHEATH INTRO SETS/USE W/INTRA-AORTIC BALLOON PRODUCT
  • ARROW-FLEX POLYURETHANE CRITICAL CARE PERCUTANEOUS SHEATH INTRODUCER SETS
  • ARROW-FLEX TRANSCEPTAL INTRODUCER SET
  • CATH LAB INTERVENT'L POLYURETHANE PERCUT SHEATH INTRODUCER SETS - ADULT
  • CATH LAB INTERVENT'L POLYURETHANE PERCUT SHEATH INTRODUCER SETS - PEDIATRIC
  • CATH LAB INTERVENT'L SUPER ARROW-FLEX PERCUT SHEATH INTRO SETS - ADULT
  • CATH LAB INTERVENT'L SUPER ARROW-FLEX PERCUT SHEATH INTRO SETS - PEDIATRIC
  • CATH LAB INTERVENT'L SUPER ARROW-FLEX RENAL ACCESS SET
  • POLYURETHANE PERCUT SHEATH INTRO SETS/USE W/INTRA-AORTIC BALLOON PRODUCT

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.