Data / Medical devices / United States / Cardiofocus, Inc.

Cardiofocus, Inc.: FDA-registered device maker in Marlborough, MA, United States, 1 510(k) clearance and 1 PMA approval

Name: Cardiofocus, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Cardiofocus, Inc. is registered with the FDA (registration 1225698) in Marlborough, MA, United States. It lists 4 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated April 1, 2016. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1225698
FEI number: 3001451473
Address: 500 Nickerson Road Suite, Marlborough, MA, United States, 01752
Owner or operator: CARDIOFOCUS, INC. (9026178)
Roles: Manufacturer, Manufacturer for export, Specification developer
First device listed: March 29, 2016
Registered through: 2026
Brand names listed: Centauri System, HeartLight Deflectable Sheath, HeartLight® System

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	OAE	3	Manufacturer	accessdata.fda.gov
Catheter, Steerable	DRA	2	Manufacturer, Specification developer	accessdata.fda.gov
Introducer, Catheter	DYB	2	Manufacturer, Specification developer	accessdata.fda.gov
Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation	OCM	3	Manufacturer for export	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 24, 2016	K152310	HeartLight Deflectable Sheath	DRA	Substantially Equivalent	Cardiofocus, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
April 1, 2016	P150026	HEARTLIGHT ENDOSCOPIC ABLATION SYSTEM	OAE	15	August 11, 2023	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
February 7, 2025	96239	Class II	Ongoing	CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is introduced percutaneously in the setting of an Electrophysiology or Catheterization Laboratory Model: 18-5000	Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.	accessdata.fda.gov

Compare with other makers

Updated March 10, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.