MEDCOMP BIO-FLEX CS CATHETER (CS100)— 510(k) K971925

Substantially Equivalent

Medical Components, Inc.

FDA 510(k) clearance K971925 for MEDCOMP BIO-FLEX CS CATHETER (CS100), Substantially Equivalent on 1998-02-23. Applicant: Medical Components, Inc..

Clearance details

Applicant: Medical Components, Inc.
Product code: Code MSD
Advisory panel: Gastroenterology, Urology
Date received: 1997-05-23
Decision date: 1998-02-23
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.