Unetixs Vascular, Inc.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

the modified devices include both design and labeling modifications – as documented in your firm’s “Regulatory Change Assessment - ENGINEERING CHANGE RECORD ECR # 0137 - Changing all applicable items from luer connections to bayonet connections” – which could significantly affect the safety and effectiveness of the device and, under 21 CFR 807.81(a)(3)(i), require a new 510(k) submission.

Passage 2

your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g).

Passage 3

The devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device with its current modifications into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).