Medical Device Division · registration 230357Active

Farapulse, Inc.

Name: Farapulse, Inc. — Medical Device Division 230357
Creator: Farapulse, Inc.
Keywords: Farapulse, Inc., Farapulse, Inc., 230357, Radiofrequency Therapy Systems, Tissue Ablation, Cardiac, Medical Device Division

Hong KongRadiofrequency Therapy Systems, Tissue Ablation, CardiacClass IIIFarapulse, Inc.

Verified

Official record identity

MDACS listing number: 230357
Model name: FARASTAR Pulsed Field Ablation Generator (61M401), FARASTAR Recording System Module (RSM) (61M407), Cable Components to Generator and RSM (61M404, 61M405, 61M406, 61M408, 61M409, 61M410, 61M411, 61M412, 61M413, 61M415, 61M416, 61M417)
Registration date: October 09, 2023
Expiry date: October 09, 2028
Source update date: March 31, 2025
Status: Active

Classification

Risk class: Class III
Published category: Radiofrequency Therapy Systems, Tissue Ablation, Cardiac

Published parties

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

Official description

Radiofrequency Therapy Systems, Tissue Ablation, Cardiac

Additional source fields

AMD nomenclature code: 18608
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.