Impella CP Introducer— 510(k) K192769

Substantially Equivalent

Abiomed, Inc.

FDA 510(k) clearance K192769 for Impella CP Introducer, Substantially Equivalent on 2019-11-18. Applicant: Abiomed, Inc..

Clearance details

Applicant: Abiomed, Inc.
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 2019-09-30
Decision date: 2019-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danvers, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

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.