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U.S. Department of Health and Human Services

Product Classification

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Device kit, balloon repair, catheter
Regulation Description Catheter balloon repair kit.
Definition Call for pmas 12/26/96 (61 fr 50706 (9/27/96)).
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDQP
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Peripheral Interventional Devices Branch (PIDB)
Submission Type PMA
Regulation Number 870.1350
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