Drivewire 24 Guidewire— 510(k) K233791
Substantially EquivalentRapid-Medical , Ltd.
FDA 510(k) clearance K233791 for Drivewire 24 Guidewire, Substantially Equivalent on 2024-07-11. Applicant: Rapid-Medical , Ltd.. Device class: 2.
Clearance details
- Applicant
- Rapid-Medical , Ltd.
- Product code
- 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 all- K260617 — Tigertriever 13 Ultra Revascularization Device
- K253062 — Tigertriever 25 Revascularization Device
- K251603 — Tigertriever 17 Ultra Revascularization Device
- DEN230064 — BraidE Embolization Assist Device
- K230429 — Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device
Adverse 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.