DeviceClearance

K231311

Substantially Equivalent

CPS Direct™ Universal slittable outer guide catheter (DS2C029)

Applicant
ABBOTT MEDICAL
Product code
DQY
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Sylmar, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code DQY

product code DQY
Death
464
Injury
4,489
Malfunction
13,721
Other
2
Total
18,676

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.