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 Number: 1225698
• FEI Number: 3001451473
• Name: CARDIOFOCUS, INC.
• Owner & Operator: CARDIOFOCUS, INC.
• Contact Address: 500 NICKERSON ROAD SUITE 500-200; Marlborough MA 01752 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 500 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	Device	Date
PMA P150026S012 CARDIOFOCUS, INC.	HeartLight X3 Endoscopic Ablation System	2021-04-06
PMA P150026S011 CARDIOFOCUS, INC.	HeartLight Catheter and HeartLight Console	2020-07-01
GUDID 00868976000147 CARDIOFOCUS, INC.	HeartLight 18-3356	2020-03-05
PMA P150026S010 CARDIOFOCUS, INC.	HeartLight System	2020-02-20
PMA P150026S009 CARDIOFOCUS, INC.	HeartLight System	2020-01-16
PMA P150026S007 CARDIOFOCUS, INC.	HeartLight Endoscopic Ablation System	2019-11-08
PMA P150026S006 CARDIOFOCUS, INC.	HeartLight Endoscopic Ablation System	2019-06-24
PMA P150026S005 CARDIOFOCUS, INC.	HeartLight Endoscopic Ablation System	2019-04-08
GUDID 00868976000178 CARDIOFOCUS, INC.	HeartLight 18-4000-27A	2018-11-05
GUDID 00868976000161 CARDIOFOCUS, INC.	HeartLight 18-4247	2018-11-05
GUDID 00868976000116 CARDIOFOCUS, INC.	HeartLight 18-2959	2018-11-05
GUDID 00868976000154 CARDIOFOCUS, INC.	HeartLight 18-3055	2018-07-06
GUDID 00868976000130 CARDIOFOCUS, INC.	HeartLight 18-1342	2018-07-06
GUDID 00868976000123 CARDIOFOCUS, INC.	HeartLight 18-1447	2018-07-06
GUDID 00868976000109 CARDIOFOCUS, INC.	HeartLight 18-2531-N250	2018-07-06
PMA P150026S002 CARDIOFOCUS, INC.	Heart Light Catheter with Excalibur Balloon	2018-05-02
PMA P150026S004 CARDIOFOCUS, INC.	HeartLight Endoscopic Ablation System	2018-04-16
PMA P150026S003 CARDIOFOCUS, INC.	HeartLight Endoscopic Ablation System	2018-01-17
PMA P150026S001 CARDIOFOCUS, INC.	HeartLight Endoscopic Ablation System	2017-08-03
PMN P150026 | OAE CARDIOFOCUS, INC.	HeartLight? System	2016-04-04
PMA P150026 CARDIOFOCUS, INC.	HEARTLIGHT ENDOSCOPIC ABLATION SYSTEM	2016-04-01
PMN K152310 | DYB CARDIOFOCUS, INC.	HeartLight Deflectable Sheath	2016-03-29
PMN K152310 | DRA CARDIOFOCUS, INC.	HeartLight Deflectable Sheath	2016-03-29
PMN K152310 CARDIOFOCUS, INC.	HeartLight Deflectable Sheath	2016-02-24
PMN K013201 CARDIOFOCUS, INC.	CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR	2002-03-18
PMN K013901 CARDIOFOCUS, INC.	MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM)	2001-12-20
PMN K011988 CARDIOFOCUS, INC.	SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C	2001-09-20
PMN K993834 CARDIOFOCUS, INC.	SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C	2000-02-04

Similar & Related FDA Registered Companies

• CARDIOFOCUS, INC.500 Nickerson Roadmarlborough, MA 01752 PMA NumberP150026 Supplement NumberS013 Date Received03/04/2022 Decision Date04/02/2022 Product Code OAE  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	5SQ08	CARDIOFOCUS INC.
NCAGE Code	8E1G7	CARDIOFOCUS, INC.
CAGE Code	5SQ08	CARDIOFOCUS, INC.
CAGE Code	8E1G7	CARDIOFOCUS, INC. CARDIOFOCUS
S.A.M. Registration	8E1G7 [68966261]	CARDIOFOCUS, INC. CARDIOFOCUS
DUNS	789077968	CARDIOFOCUS, INC.
DUNS	068966261	Cardiofocus, Inc.
SEC	0001103704	CARDIOFOCUS INC
SEC	0001465968	CardioFocus, Inc. of DELAWARE