COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY— 510(k) K122091

Unknown

Cook, Inc.

FDA 510(k) clearance K122091 for COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY, Unknown on 2013-07-29. Applicant: Cook, Inc..

Clearance details

Applicant: Cook, Inc.
Product code: Code MPB
Advisory panel: Gastroenterology, Urology
Date received: 2012-07-16
Decision date: 2013-07-29
Decision: Unknown
Clearance type: Traditional
Location: Bloomington, IN, US

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Adverse events under product code MPB

product code MPB

Death: 18
Malfunction: 1,042
Total: 1,060

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.