DeviceClearance

K170759

Substantially Equivalent

CRE Pulmonary Balloon Dilatation Catheter

Applicant
Boston Scientific Corporation
Product code
KTI
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Marlboro, MA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code KTI

product code KTI
Malfunction
642
Total
642

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.