510(k) K102482— FLASH PTA BALLOON DILATATION CATHETER 5MM X 19MM X 135CM; FLASH PTA BALLOON DILATATION CATHETER 6MM X 19MM X 135CM

Substantially Equivalent

Ostial Corporation

Clearance details

Applicant: Ostial Corporation
Product code: Code LIT
Advisory panel: Cardiovascular
Date received: 2010-08-30
Decision date: 2011-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, 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.