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U.S. Department of Health and Human Services

Product Classification

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Device system, balloon, intra-aortic and control, reprocessed
Regulation Description Intra-aortic balloon and control system.
Definition Reprocessed Single Use Device (SUD) requiring 510(k) and previously exempt from submission of validation data. As of 9/29/05 FR notice validation data is now required. http://www.fda.gov/cdrh/reprocessing/fr-list2.html
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeNKO
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Circulatory Support Devices Branch (CSDB)
Submission Type 510(k)
Regulation Number 870.3535
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible