CARDIOFOCUS, INC.

FDA Device Registration & Listing · Marlborough, MA, US · Registration 1225698

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1225698
FEI Number
3001451473
Entity Name
CARDIOFOCUS, INC.
City/State/Country
Marlborough, MA, US
Establishment Address
500 NICKERSON ROAD, SUITE 500-200, Marlborough, MA 01752, US
Establishment Type(s)
Manufacture Device in the United States for Export Only
Owner / Operator
CARDIOFOCUS, INC. (Owner Number: 9026178)
Owner / Operator Contact Address
500 NICKERSON ROAD, SUITE 500-200, Marlborough, MA 01752, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

HeartLight® System Centauri System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown Class 3 N/A 2016-04-04
OCM Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation Unknown Class 3 N/A 2026-04-02

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CARDIOFOCUS, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1225698. Last updated year: 2026. Please use registration number 1225698 when referencing this establishment in official correspondence.
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