FDA 510(k)

VPS Rhythm Device with TipTracker Technology

N.º K: K160925 · 2016-12-22

SolicitanteArrow International, Inc. (A Subsidiary of Teleflex, Inc.)

Fecha de decisión2016-12-22

Código de productoLJS

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

VPS Rhythm Device with TipTracker Technology is the device name listed in this FDA 510(k) record. The listed applicant is Arrow International, Inc. (A Subsidiary of Teleflex, Inc.). It received FDA 510(k) clearance on 2016-12-22 under 510(k) number K160925. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the VPS Rhythm Device with TipTracker Technology?

VPS Rhythm Device with TipTracker Technology is a medical device that received FDA 510(k) clearance on 2016-12-22. The listed applicant is Arrow International, Inc. (A Subsidiary of Teleflex, Inc.). The 510(k) number is K160925.

When did VPS Rhythm Device with TipTracker Technology receive FDA 510(k) clearance?

VPS Rhythm Device with TipTracker Technology received FDA 510(k) clearance on 2016-12-22, under 510(k) number K160925.

Who is the listed applicant for VPS Rhythm Device with TipTracker Technology?

The FDA 510(k) record lists Arrow International, Inc. (A Subsidiary of Teleflex, Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VPS Rhythm Device with TipTracker Technology?

The FDA product code for VPS Rhythm Device with TipTracker Technology is LJS.

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Fuente oficial

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