FDA 510(k)

C-CAT Anaesthesia Catheter kit

Numéro K : K191470 · 2019-10-25

Date de décision2019-10-25

Code produitBSO

Comité consultatifAN

DécisionSubstantially Equivalent

Résumé du dispositif

C-CAT Anaesthesia Catheter kit is the device name listed in this FDA 510(k) record. The listed applicant is Cimpax Aps. It received FDA 510(k) clearance on 2019-10-25 under 510(k) number K191470. The device is classified under product code BSO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the C-CAT Anaesthesia Catheter kit?

C-CAT Anaesthesia Catheter kit is a medical device that received FDA 510(k) clearance on 2019-10-25. The listed applicant is Cimpax Aps. The 510(k) number is K191470.

When did C-CAT Anaesthesia Catheter kit receive FDA 510(k) clearance?

C-CAT Anaesthesia Catheter kit received FDA 510(k) clearance on 2019-10-25, under 510(k) number K191470.

Who is the listed applicant for C-CAT Anaesthesia Catheter kit?

The FDA 510(k) record lists Cimpax Aps as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C-CAT Anaesthesia Catheter kit?

The FDA product code for C-CAT Anaesthesia Catheter kit is BSO.

Essais cliniques associés

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Dispositifs connexes (Code : BSO)

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Source officielle

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