K023233

Substantially Equivalent

EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM

Applicant: Ebi, L.P.
Product code: BSO
Advisory panel: Anesthesiology
Date received: 2002-09-27
Decision date: 2002-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

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.