TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS— 510(k) K022221

Unknown

Deltec, Inc.

FDA 510(k) clearance K022221 for TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS, Unknown on 2003-01-30. Applicant: Deltec, Inc..

Clearance details

Applicant: Deltec, Inc.
Product code: Code MPB
Advisory panel: Gastroenterology, Urology
Date received: 2002-07-09
Decision date: 2003-01-30
Decision: Unknown
Clearance type: Traditional
Location: St. Paul, MN, 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.