510(k) K191470

C-CAT Anaesthesia Catheter kit by Cimpax Aps — Product Code BSO

K191470 is an FDA 510(k) premarket notification submitted by Cimpax Aps for the device "C-CAT Anaesthesia Catheter kit". The FDA issued a decision of Substantially Equivalent on October 25, 2019. The device falls under product code BSO (Catheter, Conduction, Anesthetic), a Class II device regulated under 21 CFR 868.5120.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2019
Date Received
June 3, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Conduction, Anesthetic
Device Class
Class II
Regulation Number
868.5120
Review Panel
AN
Submission Type