DIAGNOSTIC ULTRASOUND IMAGING CATHETER— 510(k) K940108

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K940108 for DIAGNOSTIC ULTRASOUND IMAGING CATHETER, Substantially Equivalent on 1994-12-07. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code ITX
Advisory panel: Radiology
Date received: 1994-01-10
Decision date: 1994-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Watertown, MA, US

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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.