510(k) K250836— 14F Duo-Flow® Side X Side Double Lumen Catheter

Substantially Equivalent

Medical Components, Inc.

Clearance details

Applicant: Medical Components, Inc.
Product code: Code MPB
Advisory panel: Gastroenterology, Urology
Date received: 2025-03-20
Decision date: 2025-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Harleysville, PA, US

Adverse events under product code MPB

product code MPB

Death: 18
Malfunction: 1,042
Total: 1,060

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.