CAPIOX RX HARDSHELL RESERVOIR— 510(k) K013526

Substantially Equivalent

Terumo Cardiovascular Systems Corp.

FDA 510(k) clearance K013526 for CAPIOX RX HARDSHELL RESERVOIR, Substantially Equivalent on 2001-11-15. Applicant: Terumo Cardiovascular Systems Corp..

Clearance details

Applicant: Terumo Cardiovascular Systems Corp.
Product code: Code DTN
Advisory panel: Cardiovascular
Date received: 2001-10-23
Decision date: 2001-11-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Elkton, MD, US

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Adverse events under product code DTN

product code DTN

Death: 3
Total: 3

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.