FDA 510(k)

Needle Free Transseptal Cannula

Número K: K172934 · 2018-02-16

RequerentePressure Products Medical Device Manufacturing, LLC

Data da decisão2018-02-16

Código do produtoDRC

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Needle Free Transseptal Cannula is the device name listed in this FDA 510(k) record. The listed applicant is Pressure Products Medical Device Manufacturing, LLC. It received FDA 510(k) clearance on 2018-02-16 under 510(k) number K172934. The device is classified under product code DRC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Needle Free Transseptal Cannula?

Needle Free Transseptal Cannula is a medical device that received FDA 510(k) clearance on 2018-02-16. The listed applicant is Pressure Products Medical Device Manufacturing, LLC. The 510(k) number is K172934.

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

Needle Free Transseptal Cannula received FDA 510(k) clearance on 2018-02-16, under 510(k) number K172934.

Who is the listed applicant for Needle Free Transseptal Cannula?

The FDA 510(k) record lists Pressure Products Medical Device Manufacturing, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Needle Free Transseptal Cannula?

The FDA product code for Needle Free Transseptal Cannula is DRC.

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Outros registros que listam Pressure Products Medical Device Manufacturing, LLC como candidato(a)

K253799SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)K241042SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)K221707SafeSept® Transseptal Guidewire (SS-140)K210328SafeSept Blunt Needle K181031TSI Transseptal Introducer K172950TSN Transseptal Needle

Ver todos os 9 dispositivos →

Dispositivos Relacionados (Código: DRC)

K240246Guia de 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 K212625PathBuilder Transseptal NeedleShanghai Microport EP Medtech Co., Ltd.K210328SafeSept Blunt NeedlePressure Products Medical Device Manufacturing, LLC K172950TSN Transseptal NeedlePressure Products Medical Device Manufacturing, LLC

Fonte oficial

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