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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 Cardiovascular Devices (OHT2)
Coronary and Peripheral Interventional Devices (DHT2C)
Submission Type PMA
Regulation Number 870.1350
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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