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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameKCH FETAL BLADDER DRAINAGE CATHETER
Classification Namestent, bladder, fetal
Generic Namestent, bladder, fetal
Applicant
ROCKET MEDICAL PLC
1151 hope st.
stamford, CT 06907
HDE NumberH970001
Date Received05/06/1997
Decision Date09/30/1997
Product Code
MPR[ Registered Establishments with MPR ]
Docket Number 98M-0164
Advisory Committee Obstetrics/Gynecology
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the kch fetal bladder drainage catheter. This device is indicated for urinary tract decompression following the diagnosis of post-vesicular obstructive uropathy in fetuses 18 to 32 weeks gestational age.
Approval OrderApproval Order
Supplements: S001 S002 
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