K191532

Substantially Equivalent

The Caterpillar and Caterpillar Micro Arterial Embolization Devices

Applicant: C.R. Bard, Inc.
Product code: KRD
Advisory panel: Cardiovascular
Date received: 2019-06-10
Decision date: 2020-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Enniscorthy, IE

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.