K133861

Substantially Equivalent

FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX80CM

Applicant: Ostial Corporation
Product code: LIT
Advisory panel: Cardiovascular
Date received: 2013-12-19
Decision date: 2014-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Adverse events under product code LIT

product code LIT

Death: 27
Injury: 1,256
Malfunction: 12,127
Total: 13,410

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.