AngioVac Circuit— 510(k) K142607

Substantially Equivalent

Angiodynamics

FDA 510(k) clearance K142607 for AngioVac Circuit, Substantially Equivalent on 2014-12-11. Applicant: Angiodynamics.

Clearance details

Applicant: Angiodynamics
Product code: Code DWE
Advisory panel: Cardiovascular
Date received: 2014-09-15
Decision date: 2014-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlborough, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DWE

product code DWE

Death: 9
Malfunction: 754
Total: 763

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.