STEP-TIP CHRONIC HEMODIALYSIS CATHETER— 510(k) K040666

Substantially Equivalent

Arrow International, Inc.

FDA 510(k) clearance K040666 for STEP-TIP CHRONIC HEMODIALYSIS CATHETER, Substantially Equivalent on 2004-05-14. Applicant: Arrow International, Inc..

Clearance details

Applicant: Arrow International, Inc.
Product code: Code MSD
Advisory panel: Gastroenterology, Urology
Date received: 2004-03-15
Decision date: 2004-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reading, PA, 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.