K121933

Substantially Equivalent

NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (28CM) NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (24CM)

Applicant: Marvao Medical Devices, Ltd.
Product code: MSD
Advisory panel: Gastroenterology, Urology
Date received: 2012-07-02
Decision date: 2013-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northborough, MA, US

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.