DeviceClearance

K150946

Substantially Equivalent

FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x 135cm, FLASH Ostial System OTW-7.0mm x 12mm x 80cm, FLASH Ostial System OTW-7.0mm x 12mm x 135cm

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

Adverse events under product code LIT

product code LIT
Death
27
Injury
1,256
Malfunction
12,127
Total
13,410

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.