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U.S. Department of Health and Human Services

Product Classification

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Device occluder, internal vessel, temporary
Definition For temporarily occluding vessels during anastomosis procedures.
Physical State liquid at room temperature and gel at body temperature
Technical Method The material is thermosensitive such that it forms a gel when injected into the blood vessel, and remains gelled for the period it takes to make the anastomosis
Target Area blood vessels
Review Panel Cardiovascular
Product CodeOBC
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Structural Heart Devices Branch (SHDB)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible