EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM— 510(k) K023233

Name: FDA 510(k) clearance K023233
Creator: U.S. Food and Drug Administration
Published: 2002-12-13

Substantially Equivalent

Ebi, L.P.

FDA 510(k) clearance K023233 for EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM, Substantially Equivalent on 2002-12-13. Applicant: Ebi, L.P.. Device class: 2.

Clearance details

Applicant: Ebi, L.P.
Product code: Code BSO
Device class: Class 2
Regulation: 21 CFR 868.5120
Advisory panel: Anesthesiology
Date received: 2002-09-27
Decision date: 2002-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BSO

product code BSO

Malfunction: 688
Total: 688

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.