Data / Medical devices / Israel / QTREX Quantum Ltd
QTREX Quantum Ltd: FDA-registered device maker in Ra'anana Central, Israel, 1 510(k) clearance
QTREX Quantum Ltd is registered with the FDA (registration 3021562887) in Ra'anana Central, Israel. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 24, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021562887
- Address
- 2, Ha-Tidhar, Ra'anana Central, Israel, 4366504
- Owner or operator
- QTREX QUANTUM Ltd. (10083402)
- Roles
- Manufacturer
- First device listed
- January 27, 2022
- Registered through
- 2026
- Brand names listed
- Cannula Fixation Device, INSPIRA ART100, INSPIRA CART
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory Equipment, Cardiopulmonary Bypass | KRI | 1 | Manufacturer | accessdata.fda.gov |
| Control, Pump Speed, Cardiopulmonary Bypass | DWA | 2 | Manufacturer | accessdata.fda.gov |
| Device, Intravascular Catheter Securement | KMK | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 24, 2024 | K232788 | INSPIRA ART100 | DWA | Substantially Equivalent | Inspira Technologies Oxy B.H.N. , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Accessory Equipment, Cardiopulmonary Bypass
- All makers of Control, Pump Speed, Cardiopulmonary Bypass
- All makers of Device, Intravascular Catheter Securement
Updated May 24, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.