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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Carilex Medical, Inc.. It received FDA 510(k) clearance on 2024-04-17 under 510(k) 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. The listed applicant is Carilex Medical, Inc.. The 510(k) number is K231646.

When did Carilex VT¿200-i NX receive FDA 510(k) clearance?

Carilex VT¿200-i NX received FDA 510(k) clearance on 2024-04-17, under 510(k) number K231646.

Who is the listed applicant for Carilex VT¿200-i NX?

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

What is the FDA product code for Carilex VT¿200-i NX?

The FDA product code for Carilex VT¿200-i NX is OMP.

Other records listing Carilex Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K173407VT - 100, VT - 200K172725VT Dressing KitsK161410VT·One, VT·One 60days

Related Devices (Code: OMP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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