510(k) K252419— HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)

Substantially Equivalent

Atraverse Medical, Inc.

Clearance details

Applicant: Atraverse Medical, Inc.
Product code: Code DXF
Advisory panel: Cardiovascular
Date received: 2025-08-01
Decision date: 2025-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
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.