PTM

Syringe, Balloon Inflation, Exempt

Product code

PTM

Device name

Syringe, Balloon Inflation, Exempt

Device class

Class 2

21 CFR

21 CFR 870.1650

Medical specialty

Cardiovascular

Marketing pathway

510(K) Exempt

FDA classification definition

This product code is the class II exempt counterpart of MAV, 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 870.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.

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