Data / Medical devices / System, Catheter Control, Steerable
System, Catheter Control, Steerable (DXX): 3 FDA-registered makers in 2 countries
3 establishments in 2 countries are registered with the FDA to make System, Catheter Control, Steerable (product code DXX, Class 2, 21 CFR 870.1290). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 34 510(k) clearances under this code, the latest on August 27, 2026, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DXX
- Device class
- 2
- Regulation
- 870.1290
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| Israel | 1 |
Makers of System, Catheter Control, Steerable
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Stereotaxis, Inc. | Saint Louis, MO, United States | Complaint file establishment, Manufacturer | 3 | November 6, 2025 | 0 | 0 | 0 | api.fda.gov |
| Microbot Medical Ltd. | Yokneam Haifa, Israel | Complaint file establishment, Specification developer | 1 | September 4, 2025 | 0 | 0 | 0 | api.fda.gov |
| I-Tek Medical, Inc. | White Bear Lake, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 27, 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.