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FDA 510(k)

Livewire Electrophysiology Catheter

N.º K: K151617 · 2016-01-22

SolicitanteSurgical Instrument Service and Savings Inc.(Dba Medline Ren
Fecha de decisión2016-01-22
Código de productoNLH
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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.

Ensayos clínicos relacionados

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Otros registros que enlistan a Surgical Instrument Service and Savings Inc.(Dba Medline Ren como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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)K193563Medline ReNewal Reprocessed Harmonic ACE+7 ShearsK182588Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/DividerK170955Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorK153745Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider

Dispositivos relacionados (Código: NLH)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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 RenK240826Catheter de Electrofisiología DECANAV™ Reciclado; Catheter de Electrofisiología WEBSTER® Duo-Decapolar RecicladoSterilmed, 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.

Fuente oficial

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