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U.S. Department of Health and Human Services

Product Classification

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Device catheter, pressure monitoring, cardiac
Regulation Description Diagnostic intravascular catheter.
Definition To measure pressure within the cardiovascular system.
Physical State Catheter with sensors.
Technical Method The catheter uses sensors which directly measure the pressure.
Target Area Cardiovascular system.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeOBI
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
Third Party Review Not Third Party Eligible
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