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U.S. Department of Health and Human Services

Product Classification
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Device catheter, subclavian
Regulation Description Blood access device and accessories.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeLFJ
Submission Type 510(k)
Regulation Number 876.5540
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Implanted Blood Access Devices for Hemodialysis
Third Party Review Not Third Party Eligible
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