FDA 510(k)

Certa Catheter

Numéro K : K171193 · 2017-12-18

DemandeurFerrosan Medical Devices Sp. Z.O.O.

Date de décision2017-12-18

Code produitBSO

Comité consultatifAN

DécisionSubstantially Equivalent

Résumé du dispositif

Certa Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Ferrosan Medical Devices Sp. Z.O.O.. It received FDA 510(k) clearance on 2017-12-18 under 510(k) number K171193. 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 Certa Catheter?

Certa Catheter is a medical device that received FDA 510(k) clearance on 2017-12-18. The listed applicant is Ferrosan Medical Devices Sp. Z.O.O.. The 510(k) number is K171193.

When did Certa Catheter receive FDA 510(k) clearance?

Certa Catheter received FDA 510(k) clearance on 2017-12-18, under 510(k) number K171193.

Who is the listed applicant for Certa Catheter?

The FDA 510(k) record lists Ferrosan Medical Devices Sp. Z.O.O. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Certa Catheter?

The FDA product code for Certa Catheter is BSO.

Essais cliniques associés

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Dispositifs connexes (Code : BSO)

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Source officielle

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