510(k) K934847— NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS

Substantially Equivalent

Sorin Biomedical, Inc.

Clearance details

Applicant: Sorin Biomedical, Inc.
Product code: Code DTN
Advisory panel: Cardiovascular
Date received: 1993-10-08
Decision date: 1994-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, 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.