Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray— 510(k) K161504

Unknown

Cook Incorporated

FDA 510(k) clearance K161504 for Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray, Unknown on 2017-01-06. Applicant: Cook Incorporated.

Clearance details

Applicant: Cook Incorporated
Product code: Code MPB
Advisory panel: Gastroenterology, Urology
Date received: 2016-06-01
Decision date: 2017-01-06
Decision: Unknown
Clearance type: Special
Location: Bloomington, IN, US

Download summary PDF View on FDA.gov ↗

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.