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CARDIOFOCUS, INC.

USA · Marlborough

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Taiwan, Israel — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

4listed device types

Class I 0Class II 2Class III 2

plus 3 registration records and 5 510(k), 16 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class III 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States3 registration records, 5 510(k), 16 PMA

Manufacturer names merged into this page: CARDIOFOCUS, INC.

FDA 510(k) clearances by year

12000 · K993834

22001 · K013901

12002 · K013201

12016 · K152310

FDA listed device types

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation 1Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation 1Catheter, Steerable 1Introducer, Catheter 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K152310	HeartLight Deflectable Sheath	2016-02-24
US	K013201	CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR	2002-03-18
US	K013901	MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM)	2001-12-20

CARDIOFOCUS, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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