14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE)— 510(k) K062671

Unknown

Kendall

FDA 510(k) clearance K062671 for 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE), Unknown on 2006-11-03. Applicant: Kendall.

Clearance details

Applicant: Kendall
Product code: Code MSD
Advisory panel: Gastroenterology, Urology
Date received: 2006-09-08
Decision date: 2006-11-03
Decision: Unknown
Clearance type: Special
Location: Mansfield, MA, US

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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.