FDA Registration
Active
🇺🇸 United States
KESTRA Medical Technologies, Inc.
Reg #: 3015185344
·
FEI: 3015185344
·
Expires 2026
Products
5
Proprietary Names
3
Establishment Types
3
Classifications
5
Registration Details
- Registration Name
- KESTRA Medical Technologies, Inc.
- Registration Number
- 3015185344
- FEI Number
- 3015185344
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3933 Lake Washington Blvd, NE
- City
- Kirkland
- State
- WA
- ZIP
- 98033
- Country
- US
Regulatory Submissions
- 510(k) Number
- K233864
- PMA Number
- P200037
Owner / Operator
- Firm Name
- Kestra Medical
- Operator Number
- 10082485
- Address
- 3933 Lake Washington Blvd, NE
- City
- Kirkland
- State
- WA
- Postal Code
- 98033
- Country
- US
- Correspondent
- Beverly Magrane
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wearable Automated External Defibrillator | MVK | Class 3 | Unknown | No | 2021-08-03 |
| System, Communication, Powered | ILQ | Class 2 | Physical Medicine | No | 2022-05-31 |
| Electrocardiograph, Ambulatory (Without Analysis) | MWJ | Class 2 | Cardiovascular | No | 2024-05-15 |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | Class 2 | Cardiovascular | No | 2024-05-15 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2021-08-03 |
Proprietary Names
ASSURE® Wearable Cardioverter Defibrillator (WCD) system
ASSURE Wearable ECG
ASSURE® CareStation
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device