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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 K251185
Device Name Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020)
Applicant
Intervene
2684 Middlefield Rd., Suite E
Redwood City,  CA  94063
Applicant Contact Eric Dooley
Correspondent
Mark Smutka
6149 Valley Glen Dr.
San Jose,  CA  95123
Correspondent Contact Mark Smutka
Regulation Number870.5150
Classification Product Code
QEW  
Subsequent Product Code
KRA  
Date Received04/16/2025
Decision Date 10/22/2025
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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