HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)— 510(k) K260292

Substantially Equivalent

Atraverse Medical

FDA 510(k) clearance K260292 for HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX), Substantially Equivalent on 2026-02-27. Applicant: Atraverse Medical.

Clearance details

Applicant: Atraverse Medical
Product code: Code DXF
Advisory panel: Cardiovascular
Date received: 2026-01-29
Decision date: 2026-02-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Cardiff By The Sea, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXF

product code DXF

Death: 78
Injury: 1,126
Malfunction: 507
Other: 1
Total: 1,712

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.