510(k) K060155— 15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS

Substantially Equivalent

Spire Biomedical, Inc.

Clearance details

Applicant: Spire Biomedical, Inc.
Product code: Code MSD
Advisory panel: Gastroenterology, Urology
Date received: 2006-01-20
Decision date: 2006-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

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.