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

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..

Clearance details

Applicant: Vasca, Inc.
Product code: Code MSD
Advisory panel: Gastroenterology, Urology
Date received: 2002-09-11
Decision date: 2003-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tewksburt, MA, US

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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.