Pediatric Esophageal Atresia Anastomosis Device
PTK is the FDA product code for Pediatric Esophageal Atresia Anastomosis Device, a class III device type, regulated under 21 CFR 876.5980. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.
Classification record
- Product code
- PTK
- Device name
- Pediatric Esophageal Atresia Anastomosis Device
- FDA 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.
- Regulation
- 21 CFR 876.5980
- Device class
- Class III
- Review panel
- Gastroenterology, Urology
- Submission type
- FDA code 6
- Implant
- No
- Life sustaining or supporting
- Yes
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 0
- Ingested recalls
- 0
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code PTK.
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