PALINDROME P HEMODIALYSIS CATHETER— 510(k) K092205

Unknown

Covidien Lp, Formerly Registered AS Kendall

FDA 510(k) clearance K092205 for PALINDROME P HEMODIALYSIS CATHETER, Unknown on 2009-10-30. Applicant: Covidien Lp, Formerly Registered AS Kendall.

Clearance details

Applicant: Covidien Lp, Formerly Registered AS Kendall
Product code: Code MSD
Advisory panel: Gastroenterology, Urology
Date received: 2009-07-22
Decision date: 2009-10-30
Decision: Unknown
Clearance type: Traditional
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.