FDA 510(k)

Map-it Diagnostic Mapping Catheters

N.º K: K160390 · 2016-04-11

SolicitanteAccess Point Technologies Ep, Inc.

Fecha de decisión2016-04-11

Código de productoDRF

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Map-it Diagnostic Mapping Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Access Point Technologies Ep, Inc.. It received FDA 510(k) clearance on 2016-04-11 under 510(k) number K160390. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Map-it Diagnostic Mapping Catheters?

Map-it Diagnostic Mapping Catheters is a medical device that received FDA 510(k) clearance on 2016-04-11. The listed applicant is Access Point Technologies Ep, Inc.. The 510(k) number is K160390.

When did Map-it Diagnostic Mapping Catheters receive FDA 510(k) clearance?

Map-it Diagnostic Mapping Catheters received FDA 510(k) clearance on 2016-04-11, under 510(k) number K160390.

Who is the listed applicant for Map-it Diagnostic Mapping Catheters?

The FDA 510(k) record lists Access Point Technologies Ep, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Map-it Diagnostic Mapping Catheters?

The FDA product code for Map-it Diagnostic Mapping Catheters is DRF.

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Fuente oficial

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