MODIFICATION TO ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET AND TRAY— 510(k) K982333

Substantially Equivalent

Cook, Inc.

FDA 510(k) clearance K982333 for MODIFICATION TO ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET AND TRAY, Substantially Equivalent on 1999-02-12. Applicant: Cook, Inc..

Clearance details

Applicant: Cook, Inc.
Product code: Code MSD
Advisory panel: Gastroenterology, Urology
Date received: 1998-07-02
Decision date: 1999-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, 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.