NQV — Catheter, Suction, Tracheobronchial, Reprocessed Class I

FDA Device Classification

FDA product code NQV covers "Catheter, Suction, Tracheobronchial, Reprocessed", a Class I medical device regulated under 21 CFR 876.4680. Submissions are reviewed by the Gastroenterology, Urology panel.

Classification Details

Product Code
NQV
Device Class
Class I
Regulation Number
876.4680
Submission Type
Review Panel
AN
Medical Specialty
Gastroenterology, Urology
Implant
No

Definition

A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).