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PTTClass II

Biliary Catheter For Irrigation And Contrast Injection, Exempt

21 CFR 876.5010 / Gastroenterology, Urology
FDA source (opens on fda.gov)

PTT is the FDA product code for Biliary Catheter For Irrigation And Contrast Injection, Exempt, a class II device type, regulated under 21 CFR 876.5010. FDA's definition for this code reads: "This product code is the class II exempt counterpart of GCA, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
PTT
Device name
Biliary Catheter For Irrigation And Contrast Injection, Exempt
FDA definition
This product code is the class II exempt counterpart of GCA, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 876.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.
Regulation
21 CFR 876.5010
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
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 code