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U.S. Department of Health and Human Services

Product Classification

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Device catheter access cover, tamper-resistant
Regulation Description Percutaneous, implanted, long-term intravascular catheter.
Definition A tamper resistant catheter access cover is intended to control unauthorized access to a central venous catheter
Physical State A tamper resistant catheter access cover is intended to control unauthorized access to a central venous catheter. The device is designed to fit over the tip of the exposed IV line and is locked to prevent access
Technical Method A tamper resistant catheter access cover is intended to control unauthorized access to a central venous catheter. The device is designed to fit over the tip of the exposed IV line and is locked to prevent access
Target Area Hub or Luer access of an intravenous catheter
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodePZW
Premarket Review Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Submission Type 510(k)
Regulation Number 880.5970
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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