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U.S. Department of Health and Human Services

Product Classification
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Device reprocessed catheter introducer
Regulation Description Catheter introducer.
Definition Introduce various cardiovascular catheters into the heart and cardiovascular system
Physical State Sheath with lumen(s). Polymer-based shaft material for both introducer and dilator. Reprocessed device.
Technical Method The devices navigate to the target location and facilitate the introduction of cardiovascular catheters to the target location.
Target Area Heart and vasculature (coronary and peripheral)
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodePNE
Premarket Review Coronary and Peripheral Interventional Devices (DHT2C)
Coronary and Peripheral Interventional Devices (DHT2C)
Submission Type 510(k)
Regulation Number 870.1340
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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