LIFESITE HEMODIALYSIS ACCESS SYSTEM, CANNULA EXCHANGE KIT, INSERTION KIT, ACCESS CANNILA— 510(k) K023023

Name: FDA 510(k) clearance K023023
Creator: U.S. Food and Drug Administration
Published: 2003-12-04

Substantially Equivalent

Vasca, Inc.

FDA 510(k) clearance K023023 for LIFESITE HEMODIALYSIS ACCESS SYSTEM, CANNULA EXCHANGE KIT, INSERTION KIT, ACCESS CANNILA, Substantially Equivalent on 2003-12-04. Applicant: Vasca, Inc.. Device class: 2.

Clearance details

Applicant: Vasca, Inc.
Product code: Code MSD
Device class: Class 2
Regulation: 21 CFR 876.5540
Advisory panel: Gastroenterology, Urology
Date received: 2002-09-11
Decision date: 2003-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tewksburt, 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.