COMBINED END-MULTIPLE LATERAL HOLES EPIDURAL CATHETER (CEMLH EPIDURAL CATHETER)— 510(k) K951927

Substantially Equivalent

Csen , Ltd.

FDA 510(k) clearance K951927 for COMBINED END-MULTIPLE LATERAL HOLES EPIDURAL CATHETER (CEMLH EPIDURAL CATHETER), Substantially Equivalent on 1997-05-30. Applicant: Csen , Ltd..

Clearance details

Applicant: Csen , Ltd.
Product code: Code BSO
Advisory panel: Anesthesiology
Date received: 1995-04-24
Decision date: 1997-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Israel, IL

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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.