PTL

Wire, Guide, Catheter, Exempt

Product code

PTL

Device name

Wire, Guide, Catheter, Exempt

Device class

Class 2

21 CFR

21 CFR 870.1330

Medical specialty

Cardiovascular

Marketing pathway

510(K) Exempt

FDA classification definition

This product code is the class II exempt counterpart of DQX, 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).