NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (32CM), NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (36CM),— 510(k) K133796

Unknown

Marvao Medical Devices, Ltd.

FDA 510(k) clearance K133796 for NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (32CM), NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (36CM),, Unknown on 2014-01-31. Applicant: Marvao Medical Devices, Ltd..

Clearance details

Applicant: Marvao Medical Devices, Ltd.
Product code: Code MSD
Advisory panel: Gastroenterology, Urology
Date received: 2013-12-13
Decision date: 2014-01-31
Decision: Unknown
Clearance type: Special
Location: Northborough, MA, 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.