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U.S. Department of Health and Human Services

Product Classification

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Device catheter, ultrasound, intravascular
Regulation Description Diagnostic intravascular catheter.
Definition For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.
Physical State Catheter with ultrasound sensors that is used with an imaging system to display ultrasound image.
Technical Method Catheter with ultrasound sensors that is used with an imaging system to display ultrasound image.
Target Area Cardiovascular anatomy and physiology.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeOBJ
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Vascular Surgery Devices Branch (VSDB)
Submission Type 510(k)
Regulation Number 870.1200
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Guidance Document
  • Guidance for Industry and FDA Staff - Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers
Third Party Review Not Third Party Eligible
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