Farapulse, Inc.

22 FDA 510(k) clearances · PMA applicant

Record	Firm	Date
FARASTAR Pulsed Field Ablation (PFA) Generator; FARASTAR Mapping System Module (MSM); FARASTAR Recording System Modul (P230030/S013)	Farapulse, Inc.	2025-09-24
FARAPULSE Pulsed Field Ablation System (P230030/S014)	Farapulse, Inc.	2025-08-14
FARAPULSE Pulsed Field Ablation System (P230030/S015)	Farapulse, Inc.	2025-08-12
FARAPULSE Pulsed Field Ablation System (FARAWAVE Pulsed Field Ablation Catheter, FARAWAVE NAV Pulsed Field Ablation C (P230030/S007)	Farapulse, Inc.	2025-07-03
FARAPULSE Pulsed Field Ablation System (FARAWAVE Pulsed Field Ablation Catheter, FARASTAR Catheter Connection Cable, (P230030/S011)	Farapulse, Inc.	2025-04-03
FARAPULSE Pulsed Field Ablation System (FARAWAVE Pulsed Field Ablation Catheter, FARASTAR Catheter Connection Cable, (P230030/S010)	Farapulse, Inc.	2025-03-10
FARAPULSE Pulsed Field Ablation System (P230030/S009)	Farapulse, Inc.	2025-02-18
FARAPULSE Pulsed Field Ablation System (FARAWAVE Pulsed Field Ablation Catheter, FARASTAR Catheter Connection Cable, (P230030/S008)	Farapulse, Inc.	2025-02-08
FARAWAVE Pulsed Field Ablation Catheter (P230030/S006)	Farapulse, Inc.	2024-10-24
FARAWAVE Pulsed Field Ablation Catheter, FARAWAVE NAV Pulsed Field Ablation Catheter, FARASTAR Pulsed Field Ablation (P230030/S003)	Farapulse, Inc.	2024-10-18
FARAPULSE Pulsed Field Ablation System (P230030/S005)	Farapulse, Inc.	2024-07-05
FARAPULSE Pulsed Field Ablation System (P230030/S002)	Farapulse, Inc.	2024-06-18
FARAPULSE Pulsed Field Ablation System (P230030/S004)	Farapulse, Inc.	2024-05-03
Farapulse Pulsed Field Ablation System (P230030/S001)	Farapulse, Inc.	2024-03-13
FARAPULSE Pulsed Field Ablation System (FARAWAVE Pulsed Field Ablation Catheter, FARASTAR Catheter Connection Cable, (P230030)	Farapulse, Inc.	2024-01-30

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Every clearance here is in the API, with alerts when new ones post.