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510(k) K122105

SMI CARDIOVASCULAR PATCH by Solinas Medical, Inc. — Product Code DXZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2012
Date Received
July 17, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Device Class
Class II
Regulation Number
870.3470
Review Panel
CV
Submission Type

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  • K142461 — VASCU-GUARD Peripheral Vascular Patch (November 25, 2014)
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  • K130872 — CARDIOCEL (January 30, 2014)