DURASPAN HEMODIALYSIS LONG-TERM CATHETER— 510(k) K100169

Unknown

R4 Vascular, Inc.

FDA 510(k) clearance K100169 for DURASPAN HEMODIALYSIS LONG-TERM CATHETER, Unknown on 2010-02-18. Applicant: R4 Vascular, Inc..

Clearance details

Applicant: R4 Vascular, Inc.
Product code: Code MSD
Advisory panel: Gastroenterology, Urology
Date received: 2010-01-20
Decision date: 2010-02-18
Decision: Unknown
Clearance type: Special
Location: Maple Grove, MN, 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.