K070770

Substantially Equivalent

GORE BALLOON SHEATH

Applicant: W. L. Gore & Associates, Inc.
Product code: MJN
Advisory panel: Cardiovascular
Date received: 2007-03-20
Decision date: 2007-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, 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.