DeviceClearance

K141322

Substantially Equivalent

ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

Applicant
Cook Incorporated
Product code
PNO
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 PNO

product code PNO
Malfunction
1,646
Total
1,646

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.