FDA.reportPublic FDA data

CARDIOFOCUS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12256983001451473CARDIOFOCUS, INC.1N2026-01-01500 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 GUDIDProductPhoneEmail
00859373007433HeartLight - HeartLight X3 Disposable Motor Catheter+1(844)527-3723customerservice@cardiofocus.com
00859373007440HeartLight - HeartLight X3 Console, US+1(844)527-3723customerservice@cardiofocus.com
00859373007464HeartLight - HeartLight X3 Console, EU+1(844)527-3723customerservice@cardiofocus.com
00859373007495HeartLight - HeartLight X3 Console, JP+1(844)527-3723customerservice@cardiofocus.com
00868976000116HeartLight - Endoscopic Ablation Console (EU)+1(844)527-3723customerservice@cardiofocus.com
00868976000147HeartLight - Deflectable Sheath+1(844)527-3723customerservice@cardiofocus.com
00868976000161HeartLight - Endoscopic Ablation Console (JP)+1(844)527-3723customerservice@cardiofocus.com
00868976000178HeartLight - Endoscopic Ablation Catheter+1(844)527-3723customerservice@cardiofocus.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
523561675468339P150026HEARTLIGHT ENDOSCOPIC ABLATION SYSTEMOAE2016-04-01
523561899611616K152310HeartLight Deflectable SheathDRA2016-02-24
523561144487467

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OAE12016-04-01
DRA12016-02-24

PMA#

HeartLight® X3 Catheter with Excalibur Balloon™

2022-04-02

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 Locati...

PMN#

GUDID#