MC3 Crescent Jugular Dual Lumen Catheter— 510(k) K203409

Substantially Equivalent

Mc3, Inc.

FDA 510(k) clearance K203409 for MC3 Crescent Jugular Dual Lumen Catheter, Substantially Equivalent on 2021-05-03. Applicant: Mc3, Inc..

Clearance details

Applicant: Mc3, Inc.
Product code: Code PZS
Advisory panel: Cardiovascular
Date received: 2020-11-19
Decision date: 2021-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dexter, MI, US

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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.