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FDA 510(k)

Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled

Numéro K : K200205 · 2020-05-13

DemandeurStryker Sustainability Solutions
Date de décision2020-05-13
Code produitNLH
Comité consultatifCV
DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Autres dossiers indiquant Stryker Sustainability Solutions en tant que demandeur

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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Dispositifs connexes (Code : NLH)

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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 RenK240826Cathéter Électrophysiologique DECANAV™ Reprocessé; Cathéter Électrophysiologique WEBSTER® Duo-Decapolar ReprocesséSterilmed, 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.

Source officielle

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