PFJ — Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor Class II

FDA Device Classification

FDA product code PFJ covers "Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor", a Class II medical device regulated under 21 CFR 884.4260. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 2 recent 510(k) clearances have been granted under this product code.