510(k) K100063— HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL

Substantially Equivalent

Ev3, Inc.

Clearance details

Applicant: Ev3, Inc.
Product code: Code MJN
Advisory panel: Cardiovascular
Date received: 2010-01-11
Decision date: 2010-02-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Adverse events under product code MJN

product code MJN

Death: 31
Injury: 240
Malfunction: 827
Total: 1,098

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.