SONICATH(TM) 9F, 12 MHZ— 510(k) K902245

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K902245 for SONICATH(TM) 9F, 12 MHZ, Substantially Equivalent on 1990-10-09. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code ITX
Advisory panel: Radiology
Date received: 1990-05-18
Decision date: 1990-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Watertown, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

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.