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U.S. Department of Health and Human Services

Product Classification

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Device left atrial appendage clip, implantable
Regulation Description Implantable clip.
Definition Intended to occlude the left atrial appendage.
Physical State A clip-like device that compresses the left atrial appendage.
Technical Method Epicardially applied during a concomitant surgical procedure to physically occlude the left atrial appendage.
Target Area Left atrial appendage of the heart.
Regulation Medical Specialty General & Plastic Surgery
Review Panel Cardiovascular
Product CodePZX
Premarket Review Cardiovascular Devices (OHT2)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type 510(k)
Regulation Number 878.4300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible