NQV · Class I — Low Risk (general controls) · Gastroenterology, Urology · 21 CFR 876.4680
Classification
FDA Product Code
NQV
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 876.4680
Review panel
AN
Medical specialty
Gastroenterology, Urology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
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).