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FDA 510(k)

Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters

N.º K: K161464 · 2016-09-30

SolicitanteInnovative Health, LLC
Fecha de decisión2016-09-30
Código de productoNLH
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Health, LLC. It received FDA 510(k) clearance on 2016-09-30 under 510(k) number K161464. 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 Dynamic Tip Steerable Diagnostic Electrophysiology Catheters?

Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters is a medical device that received FDA 510(k) clearance on 2016-09-30. The listed applicant is Innovative Health, LLC. The 510(k) number is K161464.

When did Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters receive FDA 510(k) clearance?

Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters received FDA 510(k) clearance on 2016-09-30, under 510(k) number K161464.

Who is the listed applicant for Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters?

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

What is the FDA product code for Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters?

The FDA product code for Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters is NLH.

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Otros registros que enlistan a Innovative Health, LLC 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 RenK240826Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology CatheterSterilmed, 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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