Medical Device Division · registration 170255Active

Biosense Webster

Name: Biosense Webster — Medical Device Division 170255
Creator: Biosense Webster, Inc.
Keywords: Biosense Webster, Biosense Webster, 170255, Catheters, Cardiac, Electrophysiology, Medical Device Division

Hong KongCatheters, Cardiac, ElectrophysiologyClass IVBiosense Webster, Inc.

Verified

Official record identity

MDACS listing number: 170255
Model name: 6 Fr. Deflectable tip catheter (D-1079-212-S, D-1079-213-S, D-1079-214-S, D-1079-215-S, D-1079-216-S, D-1079-217-S, D-1079-228-S, D-1079-229-S, D-1079-230-S, D-1079-231-S, D-1079-234-S, D-1079-236-S, D-1079-237-S, D-1079-238-S, D-1079-323-S), 7 Fr. Deflectable tip catheter (D-1097-550-S, D-1097-551-S, D-1097-552-S, D-1097-554-S, D-1097-568-S, D-1097-569-S, D-1097-570-S, D-1097-571-S, D-1097-602-S)
Registration date: June 09, 2022
Expiry date: September 22, 2027
Source update date: September 09, 2026
Status: Active

Classification

Risk class: Class IV
Published category: Catheters, Cardiac, Electrophysiology

Published parties

Registrant / registration holder: Johnson & Johnson (Hong Kong) Limited
Manufacturer: Biosense Webster, Inc.

Official description

Catheters, Cardiac, Electrophysiology

Additional source fields

AMD nomenclature code: 18688
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
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.