The Flourish Pediatric Esophageal Atresia Device is indicated for use in lengthening atretic esophageal ends and creating an anastomosis with a nonsurgical procedure in pediatric patients, up to one year of age with esophageal atresia without a tracheoesophageal fistula (TEF), or in pediatric patients up to one year of age for whom a concurrent TEF has been closed as a result of a prior procedure. This device is indicated for atretic segments < 4 cm apart.
HUMANITARIAN DEVICE
Authorized by federal law for use in the treatment of lengthening atretic esophageal ends and creating an anastomosis with a nonsurgical procedure in pediatric patients, up to one year of age with esophageal atresia without a tracheoesophageal fistula (TEF), or in pediatric patients up to one year of age for whom a concurrent TEF has been closed as a result of a prior procedure. The effectiveness of this use has not been demonstrated.
This device requires IRB approval: H150003
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Order Number | Reference Part Number |
Instructions for Use (IFU) |
MR Status |
Oral Catheter Fr |
Oral Catheter Length cm |
Gastric Catheter Fr |
More Info |
---|---|---|---|---|---|---|---|
G47283 | FLRSH-PEA | — | N/A | 10 | 58 | 18 | Expand » |
Additional Specs
Description
-
Gastric Catheter Length cm
58
Magnet Diameter inch
0.25
|
Wire Guide Diameter inch 0.035