Cleared Traditional

C-CAT Anaesthesia Catheter kit

K191470 · Cimpax Aps · Anesthesiology
Oct 2019
Decision
144d
Days
Class 2
Risk

About This 510(k) Submission

K191470 is an FDA 510(k) clearance for the C-CAT Anaesthesia Catheter kit, a Catheter, Conduction, Anesthetic (Class II — Special Controls, product code BSO), submitted by Cimpax Aps (Slangerup, DK). The FDA issued a Cleared decision on October 25, 2019, 144 days after receiving the submission on June 3, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5120.

Submission Details

510(k) Number K191470 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 2019
Decision Date October 25, 2019
Days to Decision 144 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSO — Catheter, Conduction, Anesthetic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5120

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