DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT— 510(k) K101843

Unknown

AngioDynamics, Inc.

FDA 510(k) clearance K101843 for DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT, Unknown on 2010-10-20. Applicant: AngioDynamics, Inc..

Clearance details

Applicant: AngioDynamics, Inc.
Product code: Code MSD
Advisory panel: Gastroenterology, Urology
Date received: 2010-07-01
Decision date: 2010-10-20
Decision: Unknown
Clearance type: Traditional
Location: Latham, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MSD

product code MSD

Death: 67
Injury: 545
Malfunction: 3,661
Total: 4,273

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.