DeviceClearance

K181353

Substantially Equivalent

Lunderquist® Fixed Core Wire Guide

Applicant
Cook Incorporated
Product code
DQX
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Bloomington, IN, US
Download summary PDF View on FDA.gov ↗

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, through . 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.