K110009

Substantially Equivalent

ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE

Applicant: Cook, Inc.
Product code: DQX
Advisory panel: Cardiovascular
Date received: 2011-01-03
Decision date: 2011-02-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Bloomington, IN, US

Adverse events under product code DQX

product code DQX

Death: 298
Injury: 4,385
Malfunction: 7,203
Other: 5
Total: 11,891

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.