FDA 510(k)

SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)

Número K: K241042 · 2024-05-17

RequerentePressure Products Medical Device Manufacturing, LLC

Data da decisão2024-05-17

Código do produtoDRC

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) 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 2024-05-17 under 510(k) number K241042. 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 SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)?

SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) is a medical device that received FDA 510(k) clearance on 2024-05-17. The listed applicant is Pressure Products Medical Device Manufacturing, LLC. The 510(k) number is K241042.

When did SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) receive FDA 510(k) clearance?

SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) received FDA 510(k) clearance on 2024-05-17, under 510(k) number K241042.

Who is the listed applicant for SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)?

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 SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)?

The FDA product code for SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) 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)K221707SafeSept® Transseptal Guidewire (SS-140)K210328SafeSept Blunt Needle K181031TSI Transseptal Introducer K172950TSN Transseptal Needle K172934Needle Free Transseptal Cannula

Ver todos os 9 dispositivos →

Dispositivos Relacionados (Código: DRC)

K240246Guia de Transseptal Accusafe (GTR31180, GTR31230)Synaptic Medical Corporation 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 K172934Needle Free Transseptal CannulaPressure Products Medical Device Manufacturing, LLC

Fonte oficial

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