Medical Device Division · registration 240373ActiveFast-Cath™ Transseptal Guiding Introducer (406553, 406586, 406800, 406802, 406804, 406805, 406840, 406841, 406842, 406843, 406849, 406850, 406851, 406852, 406901, 406902, 406948, 406949, 406964, 406968, 406969, 407400, 407401, 407436, 407438), Fast-Cath™ Duo Hemostasis Introducer (406301, 406307, 406331, 406333), Fast-Cath™ Trio Hemostasis Introducer (406303, 406306, 406308, 406335, 406955, 406961, 406962, 406963), Fast-Cath™ Guiding Introducer (406820, 406844, 406845, 406846, 406847, 406848, 406853, 406854, 406855, 406856, 406857, 406868, 406870, 406871, 406872, 406885, 406894, 406898, 406943, 406965, 406967, 406975, 406976, 407404, 407405, 407406), Fast-Cath™ Hemostasis Introducer (406543, 406545, 406700, 406701, 406702, 406703, 406704, 406705, 406706, 406707, 406708, 406709, 406724)
Hong KongCatheter Introducers, VascularClass IVAbbott Medical
Official record identity
- MDACS listing number
- 240373
- Model name
- Fast-Cath™ Transseptal Guiding Introducer (406553, 406586, 406800, 406802, 406804, 406805, 406840, 406841, 406842, 406843, 406849, 406850, 406851, 406852, 406901, 406902, 406948, 406949, 406964, 406968, 406969, 407400, 407401, 407436, 407438), Fast-Cath™ Duo Hemostasis Introducer (406301, 406307, 406331, 406333), Fast-Cath™ Trio Hemostasis Introducer (406303, 406306, 406308, 406335, 406955, 406961, 406962, 406963), Fast-Cath™ Guiding Introducer (406820, 406844, 406845, 406846, 406847, 406848, 406853, 406854, 406855, 406856, 406857, 406868, 406870, 406871, 406872, 406885, 406894, 406898, 406943, 406965, 406967, 406975, 406976, 407404, 407405, 407406), Fast-Cath™ Hemostasis Introducer (406543, 406545, 406700, 406701, 406702, 406703, 406704, 406705, 406706, 406707, 406708, 406709, 406724)
- Registration date
- September 11, 2024
- Expiry date
- September 10, 2029
- Source update date
- October 25, 2024
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
Official value: IV
Published parties
- Registrant / registration holder
- Abbott Medical (Hong Kong) Limited
- Manufacturer
- Abbott Medical
Official description
Catheter Introducers, Vascular
Additional source fields
- AMD nomenclature code
- 34022
- Traditional Chinese local responsible person
- 美國雅培醫療用品(香港)有限公司
- Local responsible person phone
- 29967688
- Published manufacturer address
- 5050 Nathan Lane North, Plymouth, Minnesota, 55442, USA
About this record
This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.