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U.S. Department of Health and Human Services

Product Classification

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Device catheter, angioplasty, peripheral, transluminal
Regulation Description Percutaneous catheter.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeLIT
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Peripheral Interventional Devices Branch (PIDB)
Submission Type 510(k)
Regulation Number 870.1250
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons