Medical Device Division · registration 230358Active

Farapulse, Inc.

Name: Farapulse, Inc. — Medical Device Division 230358
Creator: Farapulse, Inc.
Keywords: Farapulse, Inc., Farapulse, Inc., 230358, Catheters, Cardiac, Electrophysiology, Ablation, Radiofrequency, Medical Device Division

Hong KongCatheters, Cardiac, Electrophysiology, Ablation, RadiofrequencyClass IVFarapulse, Inc.

Verified

Official record identity

MDACS listing number: 230358
Model name: FARADRIVE Steerable Sheath (21M401, 21M402)
Registration date: October 09, 2023
Expiry date: October 09, 2028
Source update date: March 31, 2025
Status: Active

Classification

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

Published parties

Registrant / registration holder: Boston Scientific Hong Kong Limited
Manufacturer: Farapulse, Inc.

Official description

Catheters, Cardiac, Electrophysiology, Ablation, Radiofrequency

Additional source fields

AMD nomenclature code: 18678
Local responsible person phone: 29607100
Published manufacturer address: 3715 Haven Ave, Suite 110, Menlo Park, CA 94025 UNITED STATES

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.