Catheters, Cardiac, Electrophysiology, Ablation, Radiofrequency

导管、心脏、电生理、消融、射频

Farapulse, Inc.·IV·Hong Kong MDACS·Registered October 09, 2023

Device overview

Risk class: IV
Product code: 18678
State: current
Status: N/A
Product code detail: 18678 Catheters, Cardiac, Electrophysiology, Ablation, Radiofrequency

Manufacturer (製造商)

Name: Farapulse, Inc.
Farapulse, Inc.
Address: 3715 Haven Ave, Suite 110, Menlo Park, CA 94025 UNITED STATES
3715 Haven Ave, Suite 110, Menlo Park, CA 94025 美国

Authorised representative (AR)

Name: Boston Scientific Hong Kong Limited
Phone: 29607100

Regulatory timeline

Registration date: October 09, 2023
Expiry date: October 09, 2028

Product models

FARADRIVE Steerable Sheath (21M401, 21M402)

法拉驱动可操纵护套 (21M401, 21M402)

About this record

This profile provides complete Hong Kong MDACS registration information for Catheters, Cardiac, Electrophysiology, Ablation, Radiofrequency. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.

Product Info: Catheters, Cardiac, Electrophysiology, Ablation, Radiofrequency

產品資訊： 导管、心脏、电生理、消融、射频