510(k) K970049— BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULTRA IMAGING CATHETER 2.9F/20MHZ/37411/

Substantially Equivalent

Cardiovascular Imaging Systems, Inc.

Clearance details

Applicant: Cardiovascular Imaging Systems, Inc.
Product code: Code ITX
Advisory panel: Radiology
Date received: 1997-01-06
Decision date: 1997-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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.