DeviceClearance

K100303

Substantially Equivalent

ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYY

Applicant
Angioscore, Inc.
Product code
PNO
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Fremont, CA, 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.