AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP— 510(k) K201112

Substantially Equivalent

Arrow International, Inc.

FDA 510(k) clearance K201112 for AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP, Substantially Equivalent on 2020-05-27. Applicant: Arrow International, Inc..

Clearance details

Applicant: Arrow International, Inc.
Product code: Code DSP
Advisory panel: Cardiovascular
Date received: 2020-04-27
Decision date: 2020-05-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Chelmsford, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSP

product code DSP

Death: 317
Injury: 566
Malfunction: 36,831
Other: 4
Total: 37,718

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.