CARDIOFOCUS, INC

FDA Filings

This page includes the latest FDA filings for CARDIOFOCUS, INC. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate

Latest Premarket Applications

PMAManufacturerDevice NameDate
CARDIOFOCUS, INC.
HeartLight Endoscopic Ablation System2019-11-08
CARDIOFOCUS, INC.
HeartLight Endoscopic Ablation System2019-06-24
CARDIOFOCUS, INC.
HeartLight Endoscopic Ablation System2019-04-08
CARDIOFOCUS, INC.
Heart Light Catheter with Excalibur Balloon2018-05-02
CARDIOFOCUS, INC.
HeartLight Endoscopic Ablation System2018-04-16
CARDIOFOCUS, INC.
HeartLight Endoscopic Ablation System2018-01-17
CARDIOFOCUS, INC.
HeartLight Endoscopic Ablation System2017-08-03
CARDIOFOCUS, INC.
HEARTLIGHT ENDOSCOPIC ABLATION SYSTEM2016-04-01

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
HeartLight
CARDIOFOCUS, INC.2018-11-05
HeartLight
CARDIOFOCUS, INC.2018-11-05
HeartLight
CARDIOFOCUS, INC.2018-11-05
HeartLight
CARDIOFOCUS, INC.2018-07-06
HeartLight
CARDIOFOCUS, INC.2018-07-06
HeartLight
CARDIOFOCUS, INC.2018-07-06
HeartLight
CARDIOFOCUS, INC.2018-07-06
HeartLight
CARDIOFOCUS, INC.2018-07-06

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