| Device |
septostomy catheter, reprocessed |
| Regulation Description |
Septostomy catheter. |
| Definition |
To create or enlarge an atrial septal defect in the heart. |
| Physical State |
A catheter houses a balloon or needle; may be composed of metal, polymer, or combination of both materials. Accessory tools may include dilator, sheath, and electrical components. |
| Technical Method |
A hole in tissue is created or enlarged via mechanical or electrical puncture. |
| Target Area |
The septum between the atria of the heart. |
| Regulation Medical Specialty |
Cardiovascular |
| Review Panel |
Cardiovascular |
|---|
| Product Code | QLZ |
|---|
| Premarket Review |
Circulatory Support, Structural and Vascular Devices
(DHT2B)
Circulatory Support, Structural and Vascular Devices
(DHT2B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
870.5175
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
Yes
|
| Note: This device is also exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile. |
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Recognized Consensus Standard
|
| Third Party Review |
Not Third Party Eligible |
