SORIN CONNECT DATA MANAGEMENT SYSTEM— 510(k) K131816

Substantially Equivalent

Sorin Group Deutschland GmbH

FDA 510(k) clearance K131816 for SORIN CONNECT DATA MANAGEMENT SYSTEM, Substantially Equivalent on 2013-07-23. Applicant: Sorin Group Deutschland GmbH.

Clearance details

Applicant: Sorin Group Deutschland GmbH
Product code: Code DXJ
Advisory panel: Cardiovascular
Date received: 2013-06-20
Decision date: 2013-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Munich, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXJ

product code DXJ

Death: 2
Total: 2

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.