Renal Access Cobra Catheter, Kumpe Access Catheter— 510(k) K171600

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K171600 for Renal Access Cobra Catheter, Kumpe Access Catheter, Substantially Equivalent on 2018-02-16. Applicant: Cook Incorporated.

Clearance details

Applicant: Cook Incorporated
Product code: Code KOD
Advisory panel: Gastroenterology, Urology
Date received: 2017-06-01
Decision date: 2018-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KOD

product code KOD

Death: 5
Injury: 1,129
Malfunction: 7,019
Total: 8,153

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.