Fecha de decisión2020-05-13
Código de productoNLH
Comité asesorCV
DecisiónSubstantially Equivalent
Resumen del dispositivo
Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Sustainability Solutions. It received FDA 510(k) clearance on 2020-05-13 under 510(k) number K200205. 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 Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled?
Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled is a medical device that received FDA 510(k) clearance on 2020-05-13. The listed applicant is Stryker Sustainability Solutions. The 510(k) number is K200205.
When did Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled receive FDA 510(k) clearance?
Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled received FDA 510(k) clearance on 2020-05-13, under 510(k) number K200205.
Who is the listed applicant for Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled?
The FDA 510(k) record lists Stryker Sustainability Solutions as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled?
The FDA product code for Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled is NLH.
Ensayos clínicos relacionados
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Otros registros que enlistan a Stryker Sustainability Solutions como solicitante
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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
Ver en la base de datos de la FDA →Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.