14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55— 510(k) K030502

Substantially Equivalent

Medcomp

FDA 510(k) clearance K030502 for 14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55, Substantially Equivalent on 2003-05-20. Applicant: Medcomp.

Clearance details

Applicant: Medcomp
Product code: Code MSD
Advisory panel: Gastroenterology, Urology
Date received: 2003-02-19
Decision date: 2003-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Harleysville, PA, US

Download summary PDF View on FDA.gov ↗

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.