BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG— 510(k) K112771

Substantially Equivalent

Sorin Group Italia S.R.L.

FDA 510(k) clearance K112771 for BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG, Substantially Equivalent on 2011-10-14. Applicant: Sorin Group Italia S.R.L..

Clearance details

Applicant: Sorin Group Italia S.R.L.
Product code: Code DTN
Advisory panel: Cardiovascular
Date received: 2011-09-23
Decision date: 2011-10-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Arvada, CO, 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.