Medical Device Division · registration 180142ActiveACIST
Hong KongCatheters, Vascular, Ultrasound, ImageClass IVACIST Medical Systems, Inc.
Official record identity
- MDACS listing number
- 180142
- Model name
- Kodama Coronary Imaging Catheter (017788)
- Registration date
- March 23, 2023
- Expiry date
- May 12, 2028
- Source update date
- November 28, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
Official value: IV
Published parties
- Registrant / registration holder
- Pacific Medical (Hong Kong) Company Limited
- Manufacturer
- ACIST Medical Systems, Inc.
Official description
Catheters, Vascular, Ultrasound, Image
Additional source fields
- AMD nomenclature code
- 18672
- Local responsible person phone
- 23438009
- Published manufacturer address
- 7905 Fuller Road, Eden Prairie, Minnesota, 55344, USA
- Revision number
- b
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.