CARDIAC INSIGHT, INC.

FDA Device Registration & Listing · Bellevue, WA, US · Registration 3010342616

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
3010342616
FEI Number
3010342616
Entity Name
CARDIAC INSIGHT, INC.
City/State/Country
Bellevue, WA, US
Establishment Address
2375 130th Ave NE, Suite 101, Bellevue, WA 98005, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
Cardiac Insight, Inc. (Owner Number: 10044470)
Owner / Operator Contact Address
2375 130th Ave NE, Suite 101, Bellevue, WA 98005, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K162503
PMA Number
N/A

All Registered Proprietary Names

Stealth System S300 Cardea SOLO

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 2017-03-24
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2017-03-24

Official Correspondent

Daniel Tylutki

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Cardiac Insight, Inc.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010342616. Last updated year: 2026. Please use registration number 3010342616 when referencing this establishment in official correspondence.
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