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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K221917
Device Name Stent Positioning Assistance System (SPAS)
Applicant
Seven Sons , Ltd.
65 Yigal Alon St.
Tel Aviv,  IL 67443
Applicant Contact Nancy Zhang
Correspondent
Seven Sons , Ltd.
65 Yigal Alon St.
Tel Aviv,  IL 67443
Correspondent Contact Nancy Zhang
Regulation Number870.1330
Classification Product Code
DQX  
Date Received06/30/2022
Decision Date 08/19/2022
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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