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Cardiofocus, Inc.

16 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
HeartLight Catheter, HeartLight X3 Console V2 (P150026/S015)Cardiofocus, Inc.2023-08-11
HeartLight Catheter, HeartLight X3 Console V2 (P150026/S014)Cardiofocus, Inc.2023-02-24
HeartLight® X3 Catheter with Excalibur Balloon™ (P150026/S013)Cardiofocus, Inc.2022-04-02
HeartLight X3 Endoscopic Ablation System (P150026/S012)Cardiofocus, Inc.2021-04-06
HeartLight Catheter and HeartLight Console (P150026/S011)Cardiofocus, Inc.2020-07-01
HeartLight Endoscopic Ablation System (P150026/S008)Cardiofocus, Inc.2020-05-08
HeartLight System (P150026/S010)Cardiofocus, Inc.2020-02-20
HeartLight System (P150026/S009)Cardiofocus, Inc.2020-01-16
HeartLight Endoscopic Ablation System (P150026/S007)Cardiofocus, Inc.2019-11-08
HeartLight Endoscopic Ablation System (P150026/S006)Cardiofocus, Inc.2019-06-24
HeartLight Endoscopic Ablation System (P150026/S005)Cardiofocus, Inc.2019-04-08
Heart Light Catheter with Excalibur Balloon (P150026/S002)Cardiofocus, Inc.2018-05-02
HeartLight Endoscopic Ablation System (P150026/S004)Cardiofocus, Inc.2018-04-16
HeartLight Endoscopic Ablation System (P150026/S003)Cardiofocus, Inc.2018-01-17
HeartLight Endoscopic Ablation System (P150026/S001)Cardiofocus, Inc.2017-08-03
HEARTLIGHT ENDOSCOPIC ABLATION SYSTEM (P150026)Cardiofocus, Inc.2016-04-01

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