FDA 510(k)

SafeSept Blunt Needle

N.º K: K210328 · 2021-03-05

SolicitantePressure Products Medical Device Manufacturing, LLC

Fecha de decisión2021-03-05

Código de productoDRC

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

SafeSept Blunt Needle 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 2021-03-05 under 510(k) number K210328. 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 Blunt Needle?

SafeSept Blunt Needle is a medical device that received FDA 510(k) clearance on 2021-03-05. The listed applicant is Pressure Products Medical Device Manufacturing, LLC. The 510(k) number is K210328.

When did SafeSept Blunt Needle receive FDA 510(k) clearance?

SafeSept Blunt Needle received FDA 510(k) clearance on 2021-03-05, under 510(k) number K210328.

Who is the listed applicant for SafeSept Blunt Needle?

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 Blunt Needle?

The FDA product code for SafeSept Blunt Needle 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)K221707SafeSept® Transseptal Guidewire (SS-140)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 K221707SafeSept® Transseptal Guidewire (SS-140)Pressure Products Medical Device Manufacturing, LLC K212625PathBuilder Transseptal NeedleShanghai Microport EP Medtech Co., Ltd.K172950TSN Transseptal NeedlePressure Products Medical Device Manufacturing, LLC K172934Needle Free Transseptal CannulaPressure Products Medical Device Manufacturing, LLC

Fuente oficial

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