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U.S. Department of Health and Human Services

Product Classification
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Device catheter, infusion, syringe
Regulation Description Continuous flush catheter.
Definition To provide physician specified fluids both perivascular or intraluminal to the perivascular space.
Physical State catheter, needle
Technical Method Catheter system that can perforate a vessel with the intent to deliver diagnostic or therapeutic fluids.
Target Area peripheral or coronary vessels
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeNPG
Premarket Review Office of Cardiovascular Devices (OHT2)
Coronary and Peripheral Interventional Devices (DHT2C)
Submission Type 510(k)
Regulation Number 870.1210
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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