Humanitarian Device Exemption (HDE). 21 CFR
814.116 (a). Fetal Drainage Bladder Catheter. H970001.
This life saving device was approved in under 30 days.
We obtained what we were told was the FIRST
Humanitarian Device Exemption (once the records were
computerized), we then discovered that we were second).
The proximal & distal coil tips are supported by stainless steel catheter tips that insert for enhanced drainage under ultrasonic visualization.
The proximal & distal coil tips are supported by stainless steel catheter tips that insert for enhanced drainage under ultrasonic visualization.
This catheter is for urinary tract
decompression following the diagnosis of
post-vesicular obstructive uropathy in fetuses
18 to 32 weeks gestational age.
