CARDIOFOCUS, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1225698	3001451473	CARDIOFOCUS, INC.	1	N	2026-01-01	500 NICKERSON ROAD SUITE 500-200 Marlborough MA US 01752

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00859373007433	HeartLight - HeartLight X3 Disposable Motor Catheter	+1(844)527-3723	customerservice@cardiofocus.com
00859373007440	HeartLight - HeartLight X3 Console, US	+1(844)527-3723	customerservice@cardiofocus.com
00859373007464	HeartLight - HeartLight X3 Console, EU	+1(844)527-3723	customerservice@cardiofocus.com
00859373007495	HeartLight - HeartLight X3 Console, JP	+1(844)527-3723	customerservice@cardiofocus.com
00868976000116	HeartLight - Endoscopic Ablation Console (EU)	+1(844)527-3723	customerservice@cardiofocus.com
00868976000147	HeartLight - Deflectable Sheath	+1(844)527-3723	customerservice@cardiofocus.com
00868976000161	HeartLight - Endoscopic Ablation Console (JP)	+1(844)527-3723	customerservice@cardiofocus.com
00868976000178	HeartLight - Endoscopic Ablation Catheter	+1(844)527-3723	customerservice@cardiofocus.com

cardiofocus.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
52356	1675468339	P150026	HEARTLIGHT ENDOSCOPIC ABLATION SYSTEM	OAE	2016-04-01
52356	1899611616	K152310	HeartLight Deflectable Sheath	DRA	2016-02-24
52356	1144487467

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
OAE	1	2016-04-01
DRA	1	2016-02-24

PMA#

HeartLight X3 Endoscopic Ablation System
2021-04-06
CARDIOFOCUS, INC.
HeartLight Catheter and HeartLight Console
2020-07-01
CARDIOFOCUS, INC.
HeartLight System
2020-02-20
CARDIOFOCUS, INC.
HeartLight System
2020-01-16
CARDIOFOCUS, INC.
HeartLight Endoscopic Ablation System
2019-11-08
CARDIOFOCUS, INC.
HeartLight Endoscopic Ablation System
2019-06-24
CARDIOFOCUS, INC.
HeartLight Endoscopic Ablation System
2019-04-08
CARDIOFOCUS, INC.
Heart Light Catheter with Excalibur Balloon
2018-05-02
CARDIOFOCUS, INC.
HeartLight Endoscopic Ablation System
2018-04-16
CARDIOFOCUS, INC.
HeartLight Endoscopic Ablation System
2018-01-17
CARDIOFOCUS, INC.
HeartLight Endoscopic Ablation System
2017-08-03
CARDIOFOCUS, INC.
HEARTLIGHT ENDOSCOPIC ABLATION SYSTEM
2016-04-01
CARDIOFOCUS, INC.

PMN#

HeartLight Deflectable Sheath
2016-02-24
CARDIOFOCUS, INC.
CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR
2002-03-18
CARDIOFOCUS, INC.
MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM)
2001-12-20
CARDIOFOCUS, INC.
SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C
2001-09-20
CARDIOFOCUS, INC.
SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C
2000-02-04
CARDIOFOCUS, INC.

GUDID#

HeartLight - HeartLight X3 Disposable Motor Catheter
CARDIOFOCUS, INC.
2020-05-19
HeartLight - HeartLight X3 Console, US
CARDIOFOCUS, INC.
2020-05-19
HeartLight - HeartLight X3 Console, EU
CARDIOFOCUS, INC.
2020-05-19
HeartLight - HeartLight X3 Console, JP
CARDIOFOCUS, INC.
2020-05-19
HeartLight - Deflectable Sheath
CARDIOFOCUS, INC.
2016-06-15
HeartLight - Endoscopic Ablation Console (EU)
CARDIOFOCUS, INC.
2018-10-03
HeartLight - Endoscopic Ablation Console (JP)
CARDIOFOCUS, INC.
2018-10-03
HeartLight - Endoscopic Ablation Catheter
CARDIOFOCUS, INC.
2018-10-03
HeartLight - Laser Ablation Balloon Catheter
CARDIOFOCUS, INC.
2016-06-15
HeartLight - Endoscope
CARDIOFOCUS, INC.
2016-06-15
HeartLight - Balloon Fill Media
CARDIOFOCUS, INC.
2016-06-15
HeartLight - Laser Ablation Console
CARDIOFOCUS, INC.
2016-06-15