KESTRA Medical Technologies, Inc.

FDA Device Registration & Listing · Kirkland, WA, US · Registration 3015185344

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
3015185344
FEI Number
3015185344
Entity Name
KESTRA Medical Technologies, Inc.
City/State/Country
Kirkland, WA, US
Establishment Address
3933 Lake Washington Blvd, NE, Kirkland, WA 98033, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Kestra Medical (Owner Number: 10082485)
Owner / Operator Contact Address
3933 Lake Washington Blvd, NE, Kirkland, WA 98033, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

ASSURE® Wearable Cardioverter Defibrillator (WCD) system ASSURE Wearable ECG ASSURE® CareStation

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MVK Wearable Automated External Defibrillator Unknown Class 3 N/A 2021-08-03
ILQ System, Communication, Powered Physical Medicine Class 2 890.3710 2022-05-31
MWJ Electrocardiograph, Ambulatory (Without Analysis) Cardiovascular Class 2 870.2800 2024-05-15
DXH Transmitters And Receivers, Electrocardiograph, Telephone Cardiovascular Class 2 870.2920 2024-05-15
OUG Medical Device Data System General Hospital Class 1 880.6310 2021-08-03

Official Correspondent

Beverly Magrane

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Kestra Medical
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
K820986 Dart Medical Equipment EKG MONITORS, VARIOUS MODELS 1982-04-29
K910450 Medtech Industries, Inc. CARD GUARD-3000 ECG TELEPHONE ADAPTER 1991-05-07
K761318 Cambridge Instruments, Inc. 3038 OPTION B-COMPUT. TRANS. TERMINAL 1977-01-06
K972649 Reynolds Medical , Ltd. CARDIOCALL CARDIAC EVENT RECORDER 1997-12-04
K033410 Remote Diagnostic Technologies , Ltd. TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002 2004-03-05

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0004-2016 Lifeline Systems, Incorporated 2
Philips GoSafe Mobile Help Button; 7000MHB. Personal Emergency Response System.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015185344. Last updated year: 2026. Please use registration number 3015185344 when referencing this establishment in official correspondence.
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