FDA 510(k)

VT·One, VT·One 60days

K-Number: K161410 · 2016-10-13

Decision Date2016-10-13

Product CodeOMP

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

VT·One, VT·One 60days is a medical device manufactured by Carilex Medical, Inc.. It received FDA 510(k) clearance on 2016-10-13 under approval number K161410. 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 VT·One, VT·One 60days?

VT·One, VT·One 60days is a medical device that received FDA 510(k) clearance on 2016-10-13. It is manufactured by Carilex Medical, Inc.. The 510(k) number is K161410.

When was VT·One, VT·One 60days approved by the FDA?

VT·One, VT·One 60days received FDA 510(k) clearance on 2016-10-13, under approval number K161410.

What company makes VT·One, VT·One 60days?

VT·One, VT·One 60days is manufactured by Carilex Medical, Inc..

What is the FDA product code for VT·One, VT·One 60days?

The FDA product code for VT·One, VT·One 60days is OMP.

Other Devices by Carilex Medical, Inc.

K173407VT - 100, VT - 200 K172725VT Dressing Kits K231646Carilex VT¿200-i NX

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K160487V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) SystemKci USA, Inc. K161128Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power SupplyMedela AG K150960WoundPro Negative Pressure Wound Therapy SystemPensar Medical, LLC K161935Avance Foam Dressing Kit - XLMolnlycke Health Care Us, LLC K161948Avance Gauze Dressing KitsMolnlycke Health Care Us, LLC K161797Avance Tubing, Avance Y-Connector, Avance ViewPadMolnlycke Health Care Us, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.