MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous Cannula— 510(k) K251258

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K251258 for MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous Cannula, Substantially Equivalent on 2025-06-20. Applicant: Medtronic, Inc..

Clearance details

Applicant: Medtronic, Inc.
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 2025-04-23
Decision date: 2025-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mounds View, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DWF

product code DWF

Death: 106
Injury: 386
Malfunction: 2,323
Total: 2,815

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.