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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Peripheral Mechanical Thrombectomy With Aspiration
510(k) Number K192814
Device Name Pounce Thrombus Retrieval System
Applicant
Surmodics,Inc.
9924 W. 74th St.
Eden Prairie,  MN  55344
Applicant Contact Amy Yanta
Correspondent
Surmodics,Inc.
9924 W. 74th St.
Eden Prairie,  MN  55344
Correspondent Contact Amy Yanta
Regulation Number870.5150
Classification Product Code
QEW  
Date Received10/01/2019
Decision Date 09/21/2020
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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