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U.S. Department of Health and Human Services

Product Classification
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Device intravascular bleed monitor
Regulation Description Intravascular bleed monitor.
Definition An intravascular bleed monitor is a probe, catheter, or catheter introducer that measures changes in bioimpedance and uses an algorithm to detect or monitor progression of potential internal bleeding complications.
Physical State Catheter introducer with embedded electrodes
Technical Method The device measures changes in bioimpedance and uses an algorithm to monitor progression of internal bleeding complications
Target Area Vasculature
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeQFJ
Premarket Review Office of Cardiovascular Devices (OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type 510(k)
Regulation Number 870.1345
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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