ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE— 510(k) K062531
Substantially EquivalentCordis Corp., A Johnson & Johnson Co.
FDA 510(k) clearance K062531 for ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE, Substantially Equivalent on 2006-09-22. Applicant: Cordis Corp., A Johnson & Johnson Co..
Clearance details
- Applicant
- Cordis Corp., A Johnson & Johnson Co.
- Product code
- Code NTE
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warren, NJ, 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.