FDA 510(k)

PathBuilder Transseptal Needle

N.º K: K212625 · 2022-03-23

SolicitanteShanghai Microport EP Medtech Co., Ltd.

Fecha de decisión2022-03-23

Código de productoDRC

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

PathBuilder Transseptal Needle is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Microport EP Medtech Co., Ltd.. It received FDA 510(k) clearance on 2022-03-23 under 510(k) number K212625. The device is classified under product code DRC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the PathBuilder Transseptal Needle?

PathBuilder Transseptal Needle is a medical device that received FDA 510(k) clearance on 2022-03-23. The listed applicant is Shanghai Microport EP Medtech Co., Ltd.. The 510(k) number is K212625.

When did PathBuilder Transseptal Needle receive FDA 510(k) clearance?

PathBuilder Transseptal Needle received FDA 510(k) clearance on 2022-03-23, under 510(k) number K212625.

Who is the listed applicant for PathBuilder Transseptal Needle?

The FDA 510(k) record lists Shanghai Microport EP Medtech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PathBuilder Transseptal Needle?

The FDA product code for PathBuilder Transseptal Needle is DRC.

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Otros registros que enlistan a Shanghai Microport EP Medtech Co., Ltd. como solicitante

K210313EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter K212626PathBuilder Transseptal Guiding Introducer K211530PathBuilder Steerable Introducer

Dispositivos relacionados (Código: DRC)

K240246Guía de Catéter Transseptal Accusafe (GTR31180, GTR31230)Synaptic Medical Corporation K241042SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)Pressure Products Medical Device Manufacturing, LLC K221707SafeSept® Transseptal Guidewire (SS-140)Pressure Products Medical Device Manufacturing, LLC K210328SafeSept Blunt NeedlePressure Products Medical Device Manufacturing, LLC K172950TSN Transseptal NeedlePressure Products Medical Device Manufacturing, LLC K172934Needle Free Transseptal CannulaPressure Products Medical Device Manufacturing, LLC

Fuente oficial

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