K052659

Substantially Equivalent

SPIDERX EMBOLIC PROTECTION DEVICE

Applicant: Ev3, Inc.
Product code: NTE
Advisory panel: Cardiovascular
Date received: 2005-09-27
Decision date: 2006-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, 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.