FDA 510(k)

PTFE Super Sheath Introducer 2.1

Número K: K153246 · 2016-02-12

RequerenteMedcomp (Medical Components, Inc.)

Data da decisão2016-02-12

Código do produtoDYB

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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)

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Fonte oficial

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