OTW Takeru PTCA Balloon Dilatation Catheter— 510(k) K172264

Substantially Equivalent

KANEKA Corporation

FDA 510(k) clearance K172264 for OTW Takeru PTCA Balloon Dilatation Catheter, Substantially Equivalent on 2018-03-19. Applicant: KANEKA Corporation.

Clearance details

Applicant: KANEKA Corporation
Product code: Code LOX
Advisory panel: Cardiovascular
Date received: 2017-07-27
Decision date: 2018-03-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Tokyo, JP

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, 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.