HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40— 510(k) K994105

Substantially Equivalent

Medical Components, Inc.

FDA 510(k) clearance K994105 for HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40, Substantially Equivalent on 2001-10-03. Applicant: Medical Components, Inc..

Clearance details

Applicant: Medical Components, Inc.
Product code: Code MSD
Advisory panel: Gastroenterology, Urology
Date received: 1999-12-06
Decision date: 2001-10-03
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.