DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820, 62153220, 62153620, 62154020, 62155520— 510(k) K091506

Unknown

R4 Vascular, Inc.

FDA 510(k) clearance K091506 for DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820, 62153220, 62153620, 62154020, 62155520, Unknown on 2010-01-08. Applicant: R4 Vascular, Inc..

Clearance details

Applicant: R4 Vascular, Inc.
Product code: Code MSD
Advisory panel: Gastroenterology, Urology
Date received: 2009-05-21
Decision date: 2010-01-08
Decision: Unknown
Clearance type: Traditional
Location: Maple Grove, MN, 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.