ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,— 510(k) K112587

Substantially Equivalent

Terumo Cardiovascular Systems Corp.

FDA 510(k) clearance K112587 for ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,, Substantially Equivalent on 2011-12-19. Applicant: Terumo Cardiovascular Systems Corp..

Clearance details

Applicant: Terumo Cardiovascular Systems Corp.
Product code: Code DWB
Advisory panel: Cardiovascular
Date received: 2011-09-06
Decision date: 2011-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DWB

product code DWB

Death: 2
Total: 2

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.