FDA 510(k)

LotusCatheter (Lotus No Balloon Catheter)

N.º K: K191512 · 2020-05-21

SolicitanteHakki Medical Technologies, Inc.

Fecha de decisión2020-05-21

Código de productoGBM

Comité asesorGU

DecisiónUnknown

Resumen del dispositivo

LotusCatheter (Lotus No Balloon Catheter) is the device name listed in this FDA 510(k) record. The listed applicant is Hakki Medical Technologies, Inc.. It received FDA 510(k) clearance on 2020-05-21 under 510(k) number K191512. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Preguntas frecuentes

What is the LotusCatheter (Lotus No Balloon Catheter)?

LotusCatheter (Lotus No Balloon Catheter) is a medical device that received FDA 510(k) clearance on 2020-05-21. The listed applicant is Hakki Medical Technologies, Inc.. The 510(k) number is K191512.

When did LotusCatheter (Lotus No Balloon Catheter) receive FDA 510(k) clearance?

LotusCatheter (Lotus No Balloon Catheter) received FDA 510(k) clearance on 2020-05-21, under 510(k) number K191512.

Who is the listed applicant for LotusCatheter (Lotus No Balloon Catheter)?

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

What is the FDA product code for LotusCatheter (Lotus No Balloon Catheter)?

The FDA product code for LotusCatheter (Lotus No Balloon Catheter) is GBM.

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Fuente oficial

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