MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM— 510(k) K032390

Substantially Equivalent

Ebi, L.P.

FDA 510(k) clearance K032390 for MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM, Substantially Equivalent on 2003-08-29. Applicant: Ebi, L.P..

Clearance details

Applicant: Ebi, L.P.
Product code: Code BSO
Advisory panel: Anesthesiology
Date received: 2003-08-04
Decision date: 2003-08-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Parsippany, NJ, US

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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.