FDA 510(k)

CORTRAK* 2 Equilateral Enteral Access System

Numéro K : K191340 · 2019-06-04

Date de décision2019-06-04

Code produitKNT

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

CORTRAK* 2 Equilateral Enteral Access System is the device name listed in this FDA 510(k) record. The listed applicant is Avanos Medical, Inc.. It received FDA 510(k) clearance on 2019-06-04 under 510(k) number K191340. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the CORTRAK* 2 Equilateral Enteral Access System?

CORTRAK* 2 Equilateral Enteral Access System is a medical device that received FDA 510(k) clearance on 2019-06-04. The listed applicant is Avanos Medical, Inc.. The 510(k) number is K191340.

When did CORTRAK* 2 Equilateral Enteral Access System receive FDA 510(k) clearance?

CORTRAK* 2 Equilateral Enteral Access System received FDA 510(k) clearance on 2019-06-04, under 510(k) number K191340.

Who is the listed applicant for CORTRAK* 2 Equilateral Enteral Access System?

The FDA 510(k) record lists Avanos Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORTRAK* 2 Equilateral Enteral Access System?

The FDA product code for CORTRAK* 2 Equilateral Enteral Access System is KNT.

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Source officielle

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