K965229

Substantially Equivalent

IMAGER TORQUE CATHETER

Applicant: Boston Scientific Corp
Product code: KOD
Advisory panel: Gastroenterology, Urology
Date received: 1996-12-31
Decision date: 1997-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Natick,, MA, US

Adverse events under product code KOD

product code KOD

Death: 5
Injury: 1,129
Malfunction: 7,019
Total: 8,153

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.