NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (28CM) NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (24CM)— 510(k) K121933

Name: FDA 510(k) clearance K121933
Creator: U.S. Food and Drug Administration
Published: 2013-03-14

Substantially Equivalent

Marvao Medical Devices, Ltd.

FDA 510(k) clearance K121933 for NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (28CM) NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (24CM), Substantially Equivalent on 2013-03-14. Applicant: Marvao Medical Devices, Ltd.. Device class: 2.

Clearance details

Applicant: Marvao Medical Devices, Ltd.
Product code: Code MSD
Device class: Class 2
Regulation: 21 CFR 876.5540
Advisory panel: Gastroenterology, Urology
Date received: 2012-07-02
Decision date: 2013-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northborough, MA, US

Download summary PDF View on FDA.gov ↗

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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.