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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 K221204
Device Name Excipio SV Thrombectomy Device
Applicant
Contego Medical, Inc.
3801 Lake Boone Trl.
Suite 100
Raleigh,  NC  27607
Applicant Contact Jim Clossick
Correspondent
Contego Medical, Inc.
3801 Lake Boone Trl.
Suite 100
Raleigh,  NC  27607
Correspondent Contact Jim Clossick
Regulation Number870.5150
Classification Product Code
QEW  
Date Received04/26/2022
Decision Date 06/23/2022
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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