FDA 510(k)

Reprocessed Steerable Introducer

Número K: K152090 · 2016-03-23

Data da decisão2016-03-23

Código do produtoPNE

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Reprocessed Steerable Introducer is the device name listed in this FDA 510(k) record. The listed applicant is Sterilmed, Inc.. It received FDA 510(k) clearance on 2016-03-23 under 510(k) number K152090. The device is classified under product code PNE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Reprocessed Steerable Introducer?

Reprocessed Steerable Introducer is a medical device that received FDA 510(k) clearance on 2016-03-23. The listed applicant is Sterilmed, Inc.. The 510(k) number is K152090.

When did Reprocessed Steerable Introducer receive FDA 510(k) clearance?

Reprocessed Steerable Introducer received FDA 510(k) clearance on 2016-03-23, under 510(k) number K152090.

Who is the listed applicant for Reprocessed Steerable Introducer?

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

What is the FDA product code for Reprocessed Steerable Introducer?

The FDA product code for Reprocessed Steerable Introducer is PNE.

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Outros registros que listam Sterilmed, Inc. como candidato(a)

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