TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATHETER (12.5 FR X 24 CM) WITH TRAY, TRUFLOW DUAL-LUMEN POY— 510(k) K030983

Name: FDA 510(k) clearance K030983
Creator: U.S. Food and Drug Administration
Published: 2003-04-25

Unknown

Deltec, Inc.

FDA 510(k) clearance K030983 for TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATHETER (12.5 FR X 24 CM) WITH TRAY, TRUFLOW DUAL-LUMEN POY, Unknown on 2003-04-25. Applicant: Deltec, Inc.. Device class: 2.

Clearance details

Applicant: Deltec, Inc.
Product code: Code MSD
Device class: Class 2
Regulation: 21 CFR 876.5540
Advisory panel: Gastroenterology, Urology
Date received: 2003-03-28
Decision date: 2003-04-25
Decision: Unknown
Clearance type: Special
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

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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.