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

Name: FDA 510(k) clearance K191470
Creator: U.S. Food and Drug Administration
Published: 2019-10-25

Substantially Equivalent

Cimpax Aps

FDA 510(k) clearance K191470 for C-CAT Anaesthesia Catheter kit, Substantially Equivalent on 2019-10-25. Applicant: Cimpax Aps. Device class: 2.

Clearance details

Applicant: Cimpax Aps
Product code: Code BSO
Device class: Class 2
Regulation: 21 CFR 868.5120
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 ↗

Recent devices under product code BSO

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K230603 — Arrow Non-Stimulating SnapLock Adapter (K-05520-005C) +4 more2023-08-30
K193664 — SubQKath Catheter and Needle Set2020-09-09
K200624 — Percutaneous Introducer2020-04-27

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.