K132947

Substantially Equivalent

DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS

Applicant: Boston Scientific Corp
Product code: KRA
Advisory panel: Cardiovascular
Date received: 2013-09-19
Decision date: 2013-10-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Maple Grove, MN, 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.