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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Vascular, For Promoting Embolization
510(k) Number K182390
Device Name IMPEDE-FX Embolization Plug
Applicant
Shape Memory Medical
807 Aldo Ave., Suite 109
Santa Clara,  CA  95054
Applicant Contact Meghan Reu
Correspondent
Shape Memory Medical
807 Aldo Ave., Suite 109
Santa Clara,  CA  95054
Correspondent Contact Meghan Reu
Regulation Number870.3300
Classification Product Code
KRD  
Date Received09/04/2018
Decision Date 05/23/2019
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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