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FDA 510(k), K203162, Advanix Biliary Stent with NaviFlex RX Delivery System
FDA 510(k), K203162, Advanix Biliary Stent with NaviFlex RX Delivery System
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$450.28 USD
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$450.28 USD
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510(K) Number: K203162
Device Name: Advanix Biliary Stent with NaviFlex RX Delivery System
Manufacturer: Boston Scientific Corporation
Device Classification Name: Stents, Drains And Dilators For The Biliary Ducts
Regulation Number: 876.5010
Classification Product Code: FGE
Date Received: 10/23/2020
Decision Date: 12/18/2020
Regulation Medical Specialty: Gastroenterology/Urology
Total Pages: 522
Fully Redacted Pages: 341
Content Pages: 181
Device Name: Advanix Biliary Stent with NaviFlex RX Delivery System
Manufacturer: Boston Scientific Corporation
Device Classification Name: Stents, Drains And Dilators For The Biliary Ducts
Regulation Number: 876.5010
Classification Product Code: FGE
Date Received: 10/23/2020
Decision Date: 12/18/2020
Regulation Medical Specialty: Gastroenterology/Urology
Total Pages: 522
Fully Redacted Pages: 341
Content Pages: 181
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