• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back To Search Results
Device drainage catheter with antibiotic
Regulation Description Powered suction pump.
Definition A tubular drain made from silicone or similar material and is coated with a silver containing material and is intended to drain fluids from body cavities using gravity drainage or attached to a suction pump.
Physical State A tubular drain made from silicone or similar material and is coated with a silver containing material
Technical Method Gravity drainage or attached to a suction pump
Target Area Normally any body cavity following surgery
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeOEI
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
Plastic and Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2)
Submission Type 510(k)
Regulation Number 878.4780
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
-
-