Medical Device Division · registration 170157ExpiredAGA Medical
Hong KongCatheters, Cardiac, Occluder DeliveryClass IVAGA Medical Corporation
Official record identity
- MDACS listing number
- 170157
- Model name
- Amplatzer Amulet Delivery Sheath (DS-TV45X45-12F-080, DS-TV45X45-14F-080)
- Registration date
- September 21, 2018
- Expiry date
- July 13, 2022
- Source update date
- October 25, 2024
- Status
- Expired
Classification
- Risk class
- Class IV
Official value: IV
Published parties
- Registrant / registration holder
- Abbott Medical (Hong Kong) Limited
- Manufacturer
- AGA Medical Corporation
Official description
Catheters, Cardiac, Occluder Delivery
Additional source fields
- AMD nomenclature code
- 10760
- 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
- Published remarks
- Expired.
- Revision number
- a
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.