K112892

Unknown

IMPELLA 2.5 PLUS CATHETER

Applicant: Abiomed, Inc.
Product code: PBL
Advisory panel: Cardiovascular
Date received: 2011-09-30
Decision date: 2012-09-06
Decision: Unknown
Clearance type: Special
Location: Danvers, MA, US

Adverse events under product code PBL

product code PBL

Death: 3
Total: 3

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.