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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector And Syringe, Angiographic
510(k) Number K152218
Device Name AVERT Contrast Modulation System;AVERT Contrast Modulation System;AVERT Contrast Modulation System
Applicant
Osprey Medical
5600 Rowland Rd. Suite 250
Minnetonka,  MN  55343
Applicant Contact Melanie Hess
Correspondent
Osprey Medical
5600 Rowland Rd. Suite 250
Minnetonka,  MN  55343
Correspondent Contact Melanie Hess
Regulation Number870.1650
Classification Product Code
DXT  
Date Received08/07/2015
Decision Date 09/21/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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