K030449

Substantially Equivalent

MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR

Applicant: Terumo Corp.
Product code: DTN
Advisory panel: Cardiovascular
Date received: 2003-02-11
Decision date: 2003-03-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Elkton, MD, US

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.