DeviceClearance

K122178

Substantially Equivalent

FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1

Applicant
Ostial Corporation
Product code
LOX
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mountain View, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code LOX

product code LOX
Death
190
Injury
1,498
Malfunction
9,670
Total
11,358

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.