510(k) K121848— SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM

Unknown

Medical Components, Inc.

Clearance details

Applicant: Medical Components, Inc.
Product code: Code MSD
Advisory panel: Gastroenterology, Urology
Date received: 2012-06-25
Decision date: 2012-09-21
Decision: Unknown
Clearance type: Special
Location: Harleysville, PA, US

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.