Data / Medical devices / United States / Atraverse Medical
Atraverse Medical: FDA-registered device maker in Cardiff by the Sea, CA, United States, 4 510(k) clearances
Atraverse Medical is registered with the FDA (registration 3029895042) in Cardiff by the Sea, CA, United States. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated February 27, 2026. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3029895042
- Address
- 2611 S Coast Hwy 101 # 204, Cardiff by the Sea, CA, United States, 92007
- Owner or operator
- Atraverse Medical (10089209)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- May 3, 2024
- Registered through
- 2027
- Brand names listed
- HOTWIRE RF GUIDEWIRE, HOTWIRE System RF Generator and Footswitch (optional accessory), Hotwire RF Guidewire
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Septostomy | DXF | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 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 |
|---|---|---|---|---|---|---|
| February 27, 2026 | K260292 | HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) | DXF | Substantially Equivalent | Atraverse Medical | accessdata.fda.gov |
| August 27, 2025 | K252419 | HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) | DXF | Substantially Equivalent | Atraverse Medical, Inc. | accessdata.fda.gov |
| August 12, 2025 | K252083 | HOTWIRE System RF Generator and Footswitch (optional accessory) | GEI | Substantially Equivalent | Atraverse Medical, Inc. | accessdata.fda.gov |
| May 1, 2024 | K240900 | HOTWIRE RF Guidewire | DXF | Substantially Equivalent | Atraverse Medical | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Catheter, Septostomy
Updated February 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.