PTK

Pediatric Esophageal Atresia Anastomosis Device

Product code

PTK

Device name

Pediatric Esophageal Atresia Anastomosis Device

Device class

Class 3

21 CFR

21 CFR 876.5980

Medical specialty

Gastroenterology, Urology

Marketing pathway

HDE - Humanitarian Device Exemption

Flag

Life-sustaining / life-supporting

FDA classification definition

Lengthening atretic esophageal ends < 4cm apart and creating an anastomosis with a non-surgical 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 procedure is performed with magnets inserted through an esophageal and gastric catheter.

Definition text from the FDA device classification database (U.S. federal government work, public domain).