FDA 510(k)

Livewire Electrophysiology Catheter

Número K: K151617 · 2016-01-22

RequerenteSurgical Instrument Service and Savings Inc.(Dba Medline Ren

Data da decisão2016-01-22

Código do produtoNLH

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Livewire Electrophysiology Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Instrument Service and Savings Inc.(Dba Medline Ren. It received FDA 510(k) clearance on 2016-01-22 under 510(k) number K151617. 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 Livewire Electrophysiology Catheter?

Livewire Electrophysiology Catheter is a medical device that received FDA 510(k) clearance on 2016-01-22. The listed applicant is Surgical Instrument Service and Savings Inc.(Dba Medline Ren. The 510(k) number is K151617.

When did Livewire Electrophysiology Catheter receive FDA 510(k) clearance?

Livewire Electrophysiology Catheter received FDA 510(k) clearance on 2016-01-22, under 510(k) number K151617.

Who is the listed applicant for Livewire Electrophysiology Catheter?

The FDA 510(k) record lists Surgical Instrument Service and Savings Inc.(Dba Medline Ren as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Livewire Electrophysiology Catheter?

The FDA product code for Livewire Electrophysiology Catheter is NLH.

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Dispositivos Relacionados (Código: NLH)

K252405Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic CatheterSurgical Instrument Service and Savings, Inc.K250772Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic CatheterSurgical Instrument Service and Savings, Inc.K242225Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic CatheterSurgical Instrument Service and Savings, Inc.K241224Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT)Surgical Instrument Service and Savings Inc.(Dba Medline Ren K240826Cáteter de Electrofisiologia DECANAV™ Reprocessado; Cáteter de Electrofisiologia WEBSTER® Duo-Decapolar ReprocessadoSterilmed, Inc.K241156Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (401150, 401206, 401207, 401210, 401211, 401212, 401222, 401223, 401226, 401227, 401228, 401260, 401261, 401271, 401305, 401306, 401309, 401310, 401311, 401312, 401317, 401353, 401357, 401381, 401392, 401399, 401400, 401425, 401430, 401433, 401434, 401435, 401436, 401438, 401441, 401442, 401443, 401444, 401445, 401448, 401449, 401450, 401451, 401453, 401466, 401468, 401Surgical Instrument Service and Savings, Inc.

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