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FDA 510(k)

V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...

K-Number: K160451 · 2016-06-20

ApplicantKci USA, Inc. (Kinetic Concepts, Inc.)
Decision Date2016-06-20
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ... is a medical device manufactured by Kci USA, Inc. (Kinetic Concepts, Inc.). It received FDA 510(k) clearance on 2016-06-20 under approval number K160451. 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 V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...?

V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ... is a medical device that received FDA 510(k) clearance on 2016-06-20. It is manufactured by Kci USA, Inc. (Kinetic Concepts, Inc.). The 510(k) number is K160451.

When was V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ... approved by the FDA?

V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ... received FDA 510(k) clearance on 2016-06-20, under approval number K160451.

What company makes V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...?

V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ... is manufactured by Kci USA, Inc. (Kinetic Concepts, Inc.).

What is the FDA product code for V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...?

The FDA product code for V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ... is OMP.

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Other Devices by Kci USA, Inc. (Kinetic Concepts, Inc.)

K161897PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings K162790V.A.C.ULTA Negative Pressure Wound Therapy System

Related Devices (Code: OMP)

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

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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