FDA 510(k)

AC3 Series Intra-Aortic Balloon Pump (IABP)

N.º K: K192238 · 2019-11-12

SolicitanteArrow International, Teleflex

Fecha de decisión2019-11-12

Código de productoDSP

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

AC3 Series Intra-Aortic Balloon Pump (IABP) is the device name listed in this FDA 510(k) record. The listed applicant is Arrow International, Teleflex. It received FDA 510(k) clearance on 2019-11-12 under 510(k) number K192238. The device is classified under product code DSP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the AC3 Series Intra-Aortic Balloon Pump (IABP)?

AC3 Series Intra-Aortic Balloon Pump (IABP) is a medical device that received FDA 510(k) clearance on 2019-11-12. The listed applicant is Arrow International, Teleflex. The 510(k) number is K192238.

When did AC3 Series Intra-Aortic Balloon Pump (IABP) receive FDA 510(k) clearance?

AC3 Series Intra-Aortic Balloon Pump (IABP) received FDA 510(k) clearance on 2019-11-12, under 510(k) number K192238.

Who is the listed applicant for AC3 Series Intra-Aortic Balloon Pump (IABP)?

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

What is the FDA product code for AC3 Series Intra-Aortic Balloon Pump (IABP)?

The FDA product code for AC3 Series Intra-Aortic Balloon Pump (IABP) is DSP.

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Dispositivos relacionados (Código: DSP)

K250542AC3® Range® Intra-Aortic Balloon PumpArrow International, LLC K232343AC3® Series IABPArrow International, LLC K201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPArrow International, Inc.K200634Kit de Catéter Balón Intra-Aórtico FiberOptix ArrowArrow International, Inc.K190101UltraFlex IABArrow International, Inc.K190117Fiberoptix IABArrow International, Inc.

Fuente oficial

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