Regulation Text
(a) Identification. An intravascular catheter securement device is a device with an adhesive backing that is placed over a needle or catheter and is used to keep the hub of the needle or the catheter flat and securely anchored to the skin.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter , subject to the limitations in § 880.9 .
Authority
21 U.S.C. 351,360,360c,360e,360j,360l,371.