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U.S. Department of Health and Human Services

Product Classification
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Device percutaneous catheter for electrosurgical cutting heart valve leaflets concomitant to transcatheter valve procedures
Definition The device is intended for electrosurgically splitting valve leaflets to facilitate a planned valvular procedure
Physical State The device is a non-implantable, single-use, percutaneous catheter system with electrical surgical cutting element(s)
Technical Method The device is a single-use percutaneous catheter system that will reach the target area through the vasculature and will cut the aortic leaflet(s) using electrical energy.
Target Area Aortic valve leaflets, native or bioprosthetic
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeSGO
Premarket Review Circulatory Support, Structural and Vascular Devices (DHT2B)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type 510(k)
Regulation Number 870.1254
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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