Device |
catheter, intravascular, therapeutic, long-term greater than 30 days |
Regulation Description |
Percutaneous, implanted, long-term intravascular catheter. |
Regulation Medical Specialty |
General Hospital |
Review Panel |
General Hospital |
Product Code | LJS |
Premarket Review |
Office of 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 |
Eligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Recognized Consensus Standards
|
Guidance Documents
|
Third Party Review |
Not Third Party Eligible |
|
|