ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire— 510(k) K220654
Substantially EquivalentCordis Corporation
FDA 510(k) clearance K220654 for ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire, Substantially Equivalent on 2022-04-06. Applicant: Cordis Corporation.
Clearance details
- Applicant
- Cordis Corporation
- Product code
- Code NTE
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Miami Lakes, FL, US
Adverse events under product code NTE
product code NTE- Death
- 28
- Injury
- 1,348
- Malfunction
- 771
- Total
- 2,147
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.