PD CATH— 510(k) K053123

Substantially Equivalent

Med-Conduit, Inc.

FDA 510(k) clearance K053123 for PD CATH, Substantially Equivalent on 2006-03-29. Applicant: Med-Conduit, Inc..

Clearance details

Applicant: Med-Conduit, Inc.
Product code: Code FJS
Advisory panel: Gastroenterology, Urology
Date received: 2005-11-07
Decision date: 2006-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tyngsboro, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FJS

product code FJS

Death: 34
Injury: 652
Malfunction: 576
Other: 6
Total: 1,268

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.