Terumo Pump Tubing— 510(k) K150542

Substantially Equivalent

Terumo Cardiovascular Systems Corporation

FDA 510(k) clearance K150542 for Terumo Pump Tubing, Substantially Equivalent on 2015-05-01. Applicant: Terumo Cardiovascular Systems Corporation.

Clearance details

Applicant: Terumo Cardiovascular Systems Corporation
Product code: Code DWE
Advisory panel: Cardiovascular
Date received: 2015-03-03
Decision date: 2015-05-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Ashland, 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.