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U.S. Department of Health and Human Services

Product Classification

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Device temporary cardiac support blood pump
Regulation Description Nonroller-type blood pump.
Definition Temporary circulatory support < 6 hours of use during off-pump bypass (opcab).
Physical State A catheter based axial flow impeller pump that is implanted within the heart. the pump unloads the heart by actively pumping blood from the left veitricle to the aorta for durations of 6 hours or less.
Technical Method The blood pump is used to support the circulation during surgical procedures (lasting < 6 hours) with or without the use of an oxygenator.
Target Area Intracardiac.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodePBL
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Vascular Surgery Devices Branch (VSDB)
Submission Type 510(k)
Regulation Number 870.4360
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible