Carilex VT¿200-i NX
K-Number: K231646 · 2024-04-17
ApplicantCarilex Medical, Inc.
Decision Date2024-04-17
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Carilex VT¿200-i NX is a medical device manufactured by Carilex Medical, Inc.. It received FDA 510(k) clearance on 2024-04-17 under approval number K231646. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Carilex VT¿200-i NX?
Carilex VT¿200-i NX is a medical device that received FDA 510(k) clearance on 2024-04-17. It is manufactured by Carilex Medical, Inc.. The 510(k) number is K231646.
When was Carilex VT¿200-i NX approved by the FDA?
Carilex VT¿200-i NX received FDA 510(k) clearance on 2024-04-17, under approval number K231646.
What company makes Carilex VT¿200-i NX?
Carilex VT¿200-i NX is manufactured by Carilex Medical, Inc..
What is the FDA product code for Carilex VT¿200-i NX?
The FDA product code for Carilex VT¿200-i NX is OMP.
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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.