Drivewire 35 Guidewire— 510(k) K254006

Substantially Equivalent

Rapid Medical Ltd.

FDA 510(k) clearance K254006 for Drivewire 35 Guidewire, Substantially Equivalent on 2026-07-17. Applicant: Rapid Medical Ltd..

Clearance details

Applicant: Rapid Medical Ltd.
Product code: Code MOF
Advisory panel: Cardiovascular
Date received: 2025-12-15
Decision date: 2026-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokneam, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code MOF

product code MOF

Death: 6
Injury: 137
Total: 143

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.