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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 K180722
Device Name CAPERE Thrombectomy System
Applicant
Kp Medcure, Inc.
1500 S. Sunkist St.
Suite H
Anaheim,  CA  92806
Applicant Contact Samuel Shaolian
Correspondent
Hogan Lovells US LLP
1735 Market St., Floor 23
Philadelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number870.5150
Classification Product Code
QEW  
Subsequent Product Code
KRA  
Date Received03/19/2018
Decision Date 06/11/2018
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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