Drivewire 35 Guidewire— 510(k) K254006
Substantially EquivalentRapid Medical Ltd.
FDA 510(k) clearance K254006 for Drivewire 35 Guidewire, Substantially Equivalent on 2026-07-17. Applicant: Rapid Medical Ltd.. Device class: 2.
Summary
Rapid Medical's Drivewire 35 Guidewire is filed under MOF, neurovasculature catheter guide wires. The record doesn't give lengths or diameters.
Class II, 21 CFR 870.1330. The Neurology review panel handled it as a Traditional 510(k), though the record lists Cardiovascular as the classification panel.
Rapid Medical filed from Yokneam, Israel. The decision came 214 calendar days after receipt (December 15, 2025 to July 17, 2026).
Clearance details
- Applicant
- Rapid Medical Ltd.
- Product code
- Product code MOF
- Device class
- Class 2
- Regulation
- 21 CFR 870.1330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Yokneam, IL
Recent devices under product code MOF
view allMore clearances from Rapid Medical Ltd.
view allAdverse events under product code MOF
product code MOF- Death
- 6
- Injury
- 137
- Total
- 143
Source: openFDA MAUDE database, through . 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.