K082519

Substantially Equivalent

FINECROSS MG CORONARY MICRO-GUIDE CATHETER

Applicant: Terumo Medical Corp.
Product code: KRA
Advisory panel: Cardiovascular
Date received: 2008-09-02
Decision date: 2008-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkton, MD, US

Adverse events under product code KRA

product code KRA

Death: 234
Injury: 1,029
Malfunction: 3,012
Other: 2
Total: 4,277

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.