510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191470Substantially Equivalent

C-CAT Anaesthesia Catheter kit

Cimpax a/S, Slangerup, DK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191470 is the FDA 510(k) clearance record for C-CAT Anaesthesia Catheter kit, a class II device, cleared for Cimpax Aps on under FDA product code BSO (Catheter, Conduction, Anesthetic). FDA records list one 510(k) clearance for Cimpax Aps. As of , FDA records show no recalls naming K191470.

Clearance record

Decision date
Received
(144 days to decision)
Product code
BSO Catheter, Conduction, Anesthetic
Regulation
21 CFR 868.5120
Device class
Class II
Review panel
Anesthesiology
Applicant
Cimpax Aps Lille Pilevang 4, Slangerup, DK
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BSO

Trailing 12 months

FDA records hold no clearances under product code BSO in the trailing twelve months.

FDA records show no clearances under product code BSO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BSO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260