FDA 510(k)

SafeSept® Transseptal Guidewire (SS-140)

N.º K: K221707 · 2022-09-14

SolicitantePressure Products Medical Device Manufacturing, LLC

Fecha de decisión2022-09-14

Código de productoDRC

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

SafeSept® Transseptal Guidewire (SS-140) 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 2022-09-14 under 510(k) number K221707. 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 SafeSept® Transseptal Guidewire (SS-140)?

SafeSept® Transseptal Guidewire (SS-140) is a medical device that received FDA 510(k) clearance on 2022-09-14. The listed applicant is Pressure Products Medical Device Manufacturing, LLC. The 510(k) number is K221707.

When did SafeSept® Transseptal Guidewire (SS-140) receive FDA 510(k) clearance?

SafeSept® Transseptal Guidewire (SS-140) received FDA 510(k) clearance on 2022-09-14, under 510(k) number K221707.

Who is the listed applicant for SafeSept® Transseptal Guidewire (SS-140)?

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 SafeSept® Transseptal Guidewire (SS-140)?

The FDA product code for SafeSept® Transseptal Guidewire (SS-140) is DRC.

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Otros registros que enlistan a Pressure Products Medical Device Manufacturing, LLC como solicitante

K253799SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)K241042SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)K210328SafeSept Blunt Needle K181031TSI Transseptal Introducer K172950TSN Transseptal Needle K172934Needle Free Transseptal Cannula

Ver todos los 9 dispositivos →

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 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

Fuente oficial

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