ECHOMARK CSI INTERFACE— 510(k) K910965

Name: FDA 510(k) clearance K910965
Creator: U.S. Food and Drug Administration
Published: 1991-09-17

Substantially Equivalent

Catheter Sciences Co.

FDA 510(k) clearance K910965 for ECHOMARK CSI INTERFACE, Substantially Equivalent on 1991-09-17. Applicant: Catheter Sciences Co.. Device class: 2.

Clearance details

Applicant: Catheter Sciences Co.
Product code: Code LIT
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 1991-03-06
Decision date: 1991-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Brunswick, NJ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LIT

product code LIT

Death: 27
Injury: 1,256
Malfunction: 12,127
Total: 13,410

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.