SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES— 510(k) K011916

Substantially Equivalent

Horizon Medical Products, Inc.

FDA 510(k) clearance K011916 for SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES, Substantially Equivalent on 2001-10-31. Applicant: Horizon Medical Products, Inc..

Clearance details

Applicant: Horizon Medical Products, Inc.
Product code: Code MSD
Advisory panel: Gastroenterology, Urology
Date received: 2001-06-20
Decision date: 2001-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Manchester, GA, 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.