DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NH— 510(k) K032061

Unknown

Spire Biomedical, Inc.

FDA 510(k) clearance K032061 for DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NH, Unknown on 2003-12-23. Applicant: Spire Biomedical, Inc..

Clearance details

Applicant: Spire Biomedical, Inc.
Product code: Code MSD
Advisory panel: Gastroenterology, Urology
Date received: 2003-07-03
Decision date: 2003-12-23
Decision: Unknown
Clearance type: Traditional
Location: Bedford, 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.