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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pancreatic Stent, Covered, Metallic, Removable
510(k) Number K150692
FOIA Releasable 510(k) K150692
Device Name AXIOS Stent with Electrocautery Enhanced Delivery System
Applicant
Boston Scientific Corp
453 Ravendale Dr., Suite H
Mountain View,  CA  94043
Applicant Contact Carole Sykes
Correspondent
Boston Scientific Corp
453 Ravendale Dr., Suite H
Mountain View,  CA  94043
Correspondent Contact Carole Sykes
Regulation Number876.5015
Classification Product Code
PCU  
Subsequent Product Code
KNS  
Date Received03/18/2015
Decision Date 08/05/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT02146352
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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