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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device biliary catheter for irrigation and contrast injection, exempt
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.
Product CodePTT
Regulation Number 876.5010
Device Class 2