IMPELLA 2.5 PLUS CATHETER— 510(k) K112892

Name: FDA 510(k) clearance K112892
Creator: U.S. Food and Drug Administration
Published: 2012-09-06

Unknown

Abiomed, Inc.

FDA 510(k) clearance K112892 for IMPELLA 2.5 PLUS CATHETER, Unknown on 2012-09-06. Applicant: Abiomed, Inc..

Clearance details

Applicant: Abiomed, Inc.
Product code: 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

Download summary PDF View on FDA.gov ↗

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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.