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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 K203476
Device Name CAPERE Thrombectomy System
Applicant
Vascular Medcure, Inc.
1500 S. Sunkist St.
Suite H
Anaheim,  CA  92806
Applicant Contact Jeffrey P. DuMontelle
Correspondent
Hogan Lovells US LLP
1735 Market St., Suite 2300
Philadelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number870.5150
Classification Product Code
QEW  
Subsequent Product Code
KRA  
Date Received11/25/2020
Decision Date 12/22/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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