Device |
port & catheter, implanted, subcutaneous, intravascular |
Regulation Description |
Subcutaneous, implanted, intravascular infusion port and catheter. |
Regulation Medical Specialty |
General Hospital |
Review Panel |
General Hospital |
Product Code | LJT |
Premarket Review |
Drug Delivery and General Hospital Devices, and Human Factors
(DHT3C)
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 |
Eligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Recognized Consensus Standards
|
Guidance Document
|
Third Party Review |
Not Third Party Eligible |
|
|