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U.S. Department of Health and Human Services

Product Classification
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Device peripheral temporary and retrievable stent system
Definition A peripheral temporary and retrievable stent system is a temporary scaffold placed into the peripheral vasculature via a delivery catheter system for treating stenotic lesions. The device is designed to be retrieved and removed following successful treatment.
Physical State Stent-like scaffold deployed via a catheter system.
Technical Method Mechanical dilatation.
Target Area Peripheral vasculature.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeSEU
Premarket Review Coronary and Peripheral Interventional Devices (DHT2C)
Coronary and Peripheral Interventional Devices (DHT2C)
Submission Type 510(k)
Regulation Number 870.5110
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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