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U.S. Department of Health and Human Services

Product Classification
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Device apical closure device
Regulation Description Apical closure device.
Definition This device is intended for closure of cardiac apical tissue.
Physical State The device is composed of a suture and polymeric anchor system that is placed in cardiac apical tissue using a delivery system.
Technical Method This device deploys an anchor and suture system into cardiac apical tissue to form an operative window through which apical access can be gained. The device is also used to close the opening.
Target Area Cardiac apical tissue
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodePNQ
Premarket Review Circulatory Support, Structural and Vascular Devices (DHT2B)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type 510(k)
Regulation Number 870.4510
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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