DeviceClearance

K113775

Substantially Equivalent

FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM X 135CM- 4.5MM X 14MM X 135CM-4.5MM X 19MM

Applicant
Ostial Corporation
Product code
LOX
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
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.