K062531

Substantially Equivalent

ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE

Applicant: Cordis Corp., A Johnson & Johnson Co.
Product code: NTE
Advisory panel: Cardiovascular
Date received: 2006-08-29
Decision date: 2006-09-22
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, 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.