CORTRAK* 2 Equilateral Enteral Access System
K-Number: K191340 · 2019-06-04
ApplicantAvanos Medical, Inc.
Decision Date2019-06-04
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
CORTRAK* 2 Equilateral Enteral Access System is a medical device manufactured by Avanos Medical, Inc.. It received FDA 510(k) clearance on 2019-06-04 under approval number K191340. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
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. It is manufactured by Avanos Medical, Inc.. The 510(k) number is K191340.
When was CORTRAK* 2 Equilateral Enteral Access System approved by the FDA?
CORTRAK* 2 Equilateral Enteral Access System received FDA 510(k) clearance on 2019-06-04, under approval number K191340.
What company makes CORTRAK* 2 Equilateral Enteral Access System?
CORTRAK* 2 Equilateral Enteral Access System is manufactured by Avanos Medical, Inc..
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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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.