K040301

Unknown

GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A

Applicant: Gambro Renal Products
Product code: MPB
Advisory panel: Gastroenterology, Urology
Date received: 2004-02-09
Decision date: 2004-11-01
Decision: Unknown
Clearance type: Traditional
Location: Lakewood, CO, US

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.