FDA 510(k)

PTFE Super Sheath Introducer 2.1

N.º K: K153246 · 2016-02-12

SolicitanteMedcomp (Medical Components, Inc.)

Fecha de decisión2016-02-12

Código de productoDYB

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

PTFE Super Sheath Introducer 2.1 is the device name listed in this FDA 510(k) record. The listed applicant is Medcomp (Medical Components, Inc.). It received FDA 510(k) clearance on 2016-02-12 under 510(k) number K153246. 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 PTFE Super Sheath Introducer 2.1?

PTFE Super Sheath Introducer 2.1 is a medical device that received FDA 510(k) clearance on 2016-02-12. The listed applicant is Medcomp (Medical Components, Inc.). The 510(k) number is K153246.

When did PTFE Super Sheath Introducer 2.1 receive FDA 510(k) clearance?

PTFE Super Sheath Introducer 2.1 received FDA 510(k) clearance on 2016-02-12, under 510(k) number K153246.

Who is the listed applicant for PTFE Super Sheath Introducer 2.1?

The FDA 510(k) record lists Medcomp (Medical Components, Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PTFE Super Sheath Introducer 2.1?

The FDA product code for PTFE Super Sheath Introducer 2.1 is DYB.

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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

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