Medical Device Division · registration 180466CancelledBiosense Webster
Hong KongCatheters, Vascular, GuidingClass IVBiosense Webster, Inc.
Official record identity
- MDACS listing number
- 180466
- Model name
- PREFACE Braided Guiding Sheath (301803A, 301803M, 301803MS, 301803P, 301805M)
- Registration date
- July 26, 2023
- Source update date
- September 02, 2026
- Status
- Cancelled
Official value: Delisted
Classification
- Risk class
- Class IV
Official value: IV
Published parties
- Registrant / registration holder
- Johnson & Johnson (Hong Kong) Limited
- Manufacturer
- Biosense Webster, Inc.
Official description
Catheters, Vascular, Guiding
Additional source fields
- AMD nomenclature code
- 17846
- Traditional Chinese local responsible person
- 強生 (香港) 有限公司
- Local responsible person phone
- 27386080
- Published manufacturer address
- 31 Technology Drive, Suite 200, Irvine, California, 92618, USA
- Published remarks
- Delisted.
- Revision number
- c
- Delist date
- 2026-09-02
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.