CSS-CARDIOPLEGIA SAFETY SYSTEM— 510(k) K973237

Substantially Equivalent

Medtronic Bio-Medicus, Inc.

FDA 510(k) clearance K973237 for CSS-CARDIOPLEGIA SAFETY SYSTEM, Substantially Equivalent on 1998-04-27. Applicant: Medtronic Bio-Medicus, Inc..

Clearance details

Applicant: Medtronic Bio-Medicus, Inc.
Product code: Code DWB
Advisory panel: Cardiovascular
Date received: 1997-08-28
Decision date: 1998-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

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Adverse events under product code DWB

product code DWB

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.