Pirouette High Pressure (HP)— 510(k) K172033

Substantially Equivalent

Arravasc, Ltd.

FDA 510(k) clearance K172033 for Pirouette High Pressure (HP), Substantially Equivalent on 2017-08-31. Applicant: Arravasc, Ltd..

Clearance details

Applicant: Arravasc, Ltd.
Product code: Code LIT
Advisory panel: Cardiovascular
Date received: 2017-07-05
Decision date: 2017-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Galway, IE

Download summary PDF View on FDA.gov ↗

Adverse events under product code LIT

product code LIT

Death: 27
Injury: 1,256
Malfunction: 12,127
Total: 13,410

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.