Cardiofocus Inc

FDA Filings

This page includes the latest FDA filings for Cardiofocus Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number1225698
FEI Number3001451473
NameCARDIOFOCUS, INC.
Owner & OperatorCARDIOFOCUS, INC.
Contact Address500 NICKERSON ROAD SUITE 500-200
Marlborough MA 01752 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address500 NICKERSON ROAD SUITE 500-200
Marlboro, MA 01752 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
CARDIOFOCUS, INC.
HeartLight Catheter and HeartLight Console2020-07-01
CARDIOFOCUS, INC.
HeartLight 18-33562020-03-05
CARDIOFOCUS, INC.
HeartLight System2020-02-20
CARDIOFOCUS, INC.
HeartLight System2020-01-16
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.
HeartLight 18-4000-27A2018-11-05
CARDIOFOCUS, INC.
HeartLight 18-42472018-11-05
CARDIOFOCUS, INC.
HeartLight 18-29592018-11-05
CARDIOFOCUS, INC.
HeartLight 18-30552018-07-06
CARDIOFOCUS, INC.
HeartLight 18-13422018-07-06
CARDIOFOCUS, INC.
HeartLight 18-14472018-07-06
CARDIOFOCUS, INC.
HeartLight 18-2531-N2502018-07-06
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? System2016-04-04
CARDIOFOCUS, INC.
HEARTLIGHT ENDOSCOPIC ABLATION SYSTEM2016-04-01
CARDIOFOCUS, INC.
HeartLight Deflectable Sheath2016-03-29
CARDIOFOCUS, INC.
HeartLight Deflectable Sheath2016-03-29
CARDIOFOCUS, INC.
HeartLight Deflectable Sheath2016-02-24
CARDIOFOCUS, INC.
CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR2002-03-18
CARDIOFOCUS, INC.
SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C2001-09-20
CARDIOFOCUS, INC.
SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C2000-02-04

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