FDA.report

KESTRA Medical Technologies, Inc.

Matched from indexed company URL: Kestra Medical Technologies, Inc.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30151853443015185344KESTRA Medical Technologies, Inc.1N2026-01-013933 Lake Washington Blvd, NE Kirkland WA US 98033

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2952201839473574P200037ASSURE Wearable Cardioverter Defibrillator (WCD) SystemMVK 2021-07-27
2952201556758142K233864ASSURE Wearable ECGMWJ2024-05-07
2952201139812156
2952201170860655

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
MWJ12024-05-07
MVK 12021-07-27

PMA

ASSURE Wearable Cardioverter Defibrillator system (ASSURE system)

2023-01-10

Kestra Medical Technologies, Inc.3933 Lake Washington Boulevard, N.e.suite 200kirkland, WA 98033 PMA NumberP200037 Supplement NumberS006 Date Received12/12/2022 Decision Date01/10/2023 Product Code MVK  Advisory Committee Cardiovascular Supplement Type30-da...

ASSURE Wearable Cardioverter Defibrillator (WCD) System

2022-10-27

Kestra Medical Technologies, Inc.3933 Lake Washington Boulevard, N.e.suite 200kirkland, WA 98033 PMA NumberP200037 Supplement NumberS005 Date Received09/28/2022 Decision Date10/27/2022 Product Code MVK  Advisory Committee Cardiovascular Supplement Type30-da...

Assure Wearable Cardioverter Defibrillator (WCD) system

2022-10-25

Kestra Medical Technologies, Inc.3933 Lake Washington Boulevard, N.e.suite 200kirkland, WA 98033 PMA NumberP200037 Supplement NumberS004 Date Received06/02/2022 Decision Date10/25/2022 Product Code MVK  Advisory Committee Cardiovascular Supplement Typenorma...

PMN

Applications

GUDID

Battery

2024-09-18

Kestra Medical Technologies, Inc.