Pirouette 035— 510(k) K161427

Substantially Equivalent

Arravasc Limited

FDA 510(k) clearance K161427 for Pirouette 035, Substantially Equivalent on 2016-07-30. Applicant: Arravasc Limited.

Clearance details

Applicant: Arravasc Limited
Product code: Code LIT
Advisory panel: Cardiovascular
Date received: 2016-05-23
Decision date: 2016-07-30
Decision: Substantially Equivalent
Clearance type: Special
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.