PALINDROME RT CHRONIC CATHETER— 510(k) K111817

Unknown

Covidien

FDA 510(k) clearance K111817 for PALINDROME RT CHRONIC CATHETER, Unknown on 2011-08-30. Applicant: Covidien.

Clearance details

Applicant: Covidien
Product code: Code MSD
Advisory panel: Gastroenterology, Urology
Date received: 2011-06-27
Decision date: 2011-08-30
Decision: Unknown
Clearance type: Special
Location: Mansfield, MA, 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.