K113658

Substantially Equivalent

AMPLATZER VASCULAR PLUG 4

Applicant: Aga Medical Corp.
Product code: KRD
Advisory panel: Cardiovascular
Date received: 2011-12-12
Decision date: 2012-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Adverse events under product code KRD

product code KRD

Death: 119
Injury: 1,869
Malfunction: 7,015
Other: 1
Total: 9,004

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.