Data / Medical devices / United States / Intervention Tech, Inc
Intervention Tech, Inc: FDA-registered device maker in Flagstaff, AZ, United States, 1 510(k) clearance
Intervention Tech, Inc is registered with the FDA (registration 3046274217) in Flagstaff, AZ, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 6, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3046274217
- Address
- 2201 N Gemini Dr Suite 138, Flagstaff, AZ, United States, 86001
- Owner or operator
- Intervention Tech, Inc (10095938)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- May 26, 2026
- Registered through
- 2027
- Brand names listed
- KardiaPSI
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Balloon Aortic Valvuloplasty | OZT | 2 | Complaint file establishment, Specification developer | 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 6, 2026 | K253855 | KardiaPSI Balloon Catheter | OZT | Substantially Equivalent | Intervention Tech, Inc. ; dba Corvention | accessdata.fda.gov |
Compare with other makers
Updated May 6, 2026. 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.