K100451

Substantially Equivalent

GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132

Applicant: Gambro Renal Products, Inc.
Product code: MPB
Advisory panel: Gastroenterology, Urology
Date received: 2010-02-17
Decision date: 2010-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

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Adverse events under product code MPB

product code MPB

Death: 18
Malfunction: 1,042
Total: 1,060

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.