HOTWIRE RF Guidewire— 510(k) K240900

Substantially Equivalent

Atraverse Medical

FDA 510(k) clearance K240900 for HOTWIRE RF Guidewire, Substantially Equivalent on 2024-05-01. Applicant: Atraverse Medical.

Clearance details

Applicant: Atraverse Medical
Product code: Code DXF
Advisory panel: Cardiovascular
Date received: 2024-04-01
Decision date: 2024-05-01
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.