DIAGNOSTIC CATHETER SYSTEM— 510(k) K091250

Substantially Equivalent

Cardinal Health, Inc.

FDA 510(k) clearance K091250 for DIAGNOSTIC CATHETER SYSTEM, Substantially Equivalent on 2009-05-22. Applicant: Cardinal Health, Inc..

Clearance details

Applicant: Cardinal Health, Inc.
Product code: Code EOQ
Advisory panel: Ear, Nose, Throat
Date received: 2009-04-28
Decision date: 2009-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcgaw Park, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EOQ

product code EOQ

Death: 135
Injury: 2,863
Malfunction: 21,662
Total: 24,660

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.