CVIS INSIGHT IMAGING CATHETERS— 510(k) K911414

Substantially Equivalent

Cardiovascular Imaging Systems, Inc.

FDA 510(k) clearance K911414 for CVIS INSIGHT IMAGING CATHETERS, Substantially Equivalent on 1991-09-11. Applicant: Cardiovascular Imaging Systems, Inc..

Clearance details

Applicant: Cardiovascular Imaging Systems, Inc.
Product code: Code ITX
Advisory panel: Radiology
Date received: 1991-04-01
Decision date: 1991-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, 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.