Device |
intrauterine tamponade balloon |
Regulation Description |
Obstetric-gynecologic specialized manual instrument. |
Definition |
provides temporary control or reduction of postpartum uterine bleeding |
Physical State |
The device consists of a catheter with a balloon at the distal end. The balloon is distended to achieve tamponade or reduction of post partum uterine bleeding. |
Technical Method |
The clinician passes the balloon through the vagina and cervix into the uterus. Then, he/she distends the balloon and closely monitors the patient's bleeding. |
Target Area |
uterus, cervix, vagina |
Regulation Medical Specialty |
Obstetrics/Gynecology |
Review Panel |
Obstetrics/Gynecology |
Product Code | OQY |
Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Reproductive, Gynecology and Urology Devices
(DHT3B)
|
Submission Type |
510(k)
|
Regulation Number |
884.4530
|
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 |
|
|