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U.S. Department of Health and Human Services

Product Classification

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Device port, protector/cushion
Regulation Description Subcutaneous, implanted, intravascular infusion port and catheter.
Definition Intended to cushion and protect the localized area surrounding the implanted port and indicated for subjects having implanted subcutaneous or intravascular infusion ports.
Physical State Device is a foam ring with adhesive that is placed on intact skin over the port access site. The foam ring can be any defined shape that covers the port. The foam provides a barrier to the implanted port.
Technical Method Device is applied on top of intact skin and provides a protection barrier over the implanted port.
Target Area The device is used on intact skin.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeOBK
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 880.5965
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
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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