C-CAT Anaesthesia Catheter kit— 510(k) K191470

Substantially Equivalent

Cimpax Aps

FDA 510(k) clearance K191470 for C-CAT Anaesthesia Catheter kit, Substantially Equivalent on 2019-10-25. Applicant: Cimpax Aps.

Clearance details

Applicant: Cimpax Aps
Product code: Code BSO
Advisory panel: Anesthesiology
Date received: 2019-06-03
Decision date: 2019-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Slangerup, DK

Download summary PDF View on FDA.gov ↗

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.