MC3 QuickFlow Dual Lumen Catheter— 510(k) K171610

Substantially Equivalent

Mc3 Incorporated

FDA 510(k) clearance K171610 for MC3 QuickFlow Dual Lumen Catheter, Substantially Equivalent on 2017-11-16. Applicant: Mc3 Incorporated.

Clearance details

Applicant: Mc3 Incorporated
Product code: Code PZS
Advisory panel: Cardiovascular
Date received: 2017-06-01
Decision date: 2017-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dexter, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PZS

product code PZS

Death: 17
Total: 17

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.