Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030721635

FEI Number

3030721635

Entity Name

ICENTIA LLC

City/State/Country

Burlington, VT, US

Establishment Address

106 Main Street, Burlington, VT 05401, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Icentia LLC (Owner Number: 10090390)

Owner / Operator Contact Address

106 Main Street, Burlington, VT 05401, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K223049

PMA Number

N/A

All Registered Proprietary Names

CardioSTAT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DSH	Recorder, Magnetic Tape, Medical	Cardiovascular	Class 2	870.2800	2025-12-16
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2025-12-16

Official Correspondent

Yannick Le Devehat

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Icentia LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K935043	Siemens Medical Electronics	SIEMENS CLINICAL WORK STATION	1995-04-07
K170948	Acutus Medical, Inc.	AcQMap High Resolution Imaging and Mapping System	2017-10-16
K242016	ABBOTT MEDICAL	EnSite X EP System	2024-08-09
K172182	St. Jude Medical (Now Part of the Abbott Medical)	QUANTIEN Measurement System	2017-08-18
K252013	ABBOTT MEDICAL	EnSite X EP System	2025-09-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2016	Biosense Webster, Inc.	2	Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
Z-0032-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.
Z-0033-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 633.
Z-0034-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 641
Z-0035-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 658

Similar Registrations

Registration Number	Establishment Name	Location
3014226707	BARDY DIAGNOSTICS, INC.	Bellevue, WA, US
3003584029	Braemar Manufacturing, LLC	San Diego, CA, US
1527715	SCOTTCARE CORPORATION	CLEVELAND, OH, US
3000126629	Philips Electronics Ltd	Mississauga Ontario, CA
3003971136	EDAN INSTRUMENTS, INC.	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030721635. Last updated year: 2026. Please use registration number 3030721635 when referencing this establishment in official correspondence.