FDA 510(k)

TSI Transseptal Introducer

N.º K: K181031 · 2018-10-26

SolicitantePressure Products Medical Device Manufacturing, LLC

Fecha de decisión2018-10-26

Código de productoDYB

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

TSI Transseptal Introducer 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 2018-10-26 under 510(k) number K181031. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the TSI Transseptal Introducer?

TSI Transseptal Introducer is a medical device that received FDA 510(k) clearance on 2018-10-26. The listed applicant is Pressure Products Medical Device Manufacturing, LLC. The 510(k) number is K181031.

When did TSI Transseptal Introducer receive FDA 510(k) clearance?

TSI Transseptal Introducer received FDA 510(k) clearance on 2018-10-26, under 510(k) number K181031.

Who is the listed applicant for TSI Transseptal Introducer?

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 TSI Transseptal Introducer?

The FDA product code for TSI Transseptal Introducer is DYB.

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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)K210328SafeSept Blunt Needle K172950TSN Transseptal Needle K172934Needle Free Transseptal Cannula

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Dispositivos relacionados (Código: DYB)

K253526NAMIC Dilator and SheathMedline Industries, LP K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLC K261242SimplGuidePendracare K261950Health Line Tearaway IntroducerHealth Line International Corporation K261492FieldFlex Steerable SheathCenterPoint Systems, LLC K260606Echo Large Bore Introducer SheathEcho Medical, LLC

Fuente oficial

Ver en la base de datos de la FDA →

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