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FDA 510(k)

Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter

Número K: K153006 · 2016-06-23

RequerenteSterilmed, Inc.
Data da decisão2016-06-23
Código do produtoNLH
Comité consultivoCV
DecisãoSubstantially Equivalent

Resumo do dispositivo

Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Sterilmed, Inc.. It received FDA 510(k) clearance on 2016-06-23 under 510(k) number K153006. The device is classified under product code NLH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter?

Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter is a medical device that received FDA 510(k) clearance on 2016-06-23. The listed applicant is Sterilmed, Inc.. The 510(k) number is K153006.

When did Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter receive FDA 510(k) clearance?

Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter received FDA 510(k) clearance on 2016-06-23, under 510(k) number K153006.

Who is the listed applicant for Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter?

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 Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter?

The FDA product code for Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter is NLH.

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Fonte oficial

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