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U.S. Department of Health and Human Services

Product Classification
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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 CodeOQY
Premarket Review Reproductive, Gynecology and Urology Devices (DHT3B)
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
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