CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING— 510(k) K061527

Substantially Equivalent

Sorin Group Italia S.R.L.

FDA 510(k) clearance K061527 for CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING, Substantially Equivalent on 2006-06-27. 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: 2006-06-02
Decision date: 2006-06-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Waltham, MA, 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.