K092315

Substantially Equivalent

SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR

Applicant: Sorin Group Italia S.R.L.
Product code: DTN
Advisory panel: Cardiovascular
Date received: 2009-07-30
Decision date: 2009-08-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Waltham, MA, 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.