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U.S. Department of Health and Human Services

Product Classification
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Device endovascular suturing system
Regulation Description Endovascular Suturing System.
Definition Provides fixation and sealing between and endovascular graft and the native artery.
Physical State The system is comprised of the implant device and an endovascular delivery device used to implant the endovascular suture.
Technical Method Uses a metallic implant, delivered through a catheter-based system, to affix the material of an endovascular graft to native vessel
Target Area The implant is to be placed at the proximal end of an aortic aneurysm.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeOTD
Premarket Review Circulatory Support, Structural and Vascular Devices (DHT2B)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type 510(k)
Regulation Number 870.3460
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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