PUMP TUBING— 510(k) K013578

Substantially Equivalent

Terumo Cardiovascular Systems Corp.

FDA 510(k) clearance K013578 for PUMP TUBING, Substantially Equivalent on 2002-01-22. Applicant: Terumo Cardiovascular Systems Corp..

Clearance details

Applicant: Terumo Cardiovascular Systems Corp.
Product code: Code DWE
Advisory panel: Cardiovascular
Date received: 2001-10-29
Decision date: 2002-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkton, MD, US

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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.