DeviceClearance

K182713

Substantially Equivalent

Scoreflex PTA Scoring Balloon Catheter

Applicant
Orbusneich Medical Trading, Inc.
Product code
PNO
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Fort Lauderdale, FL, 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.