DeviceClearance

Product code OYI— Anesthesiology

BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER

Classification name
Non-Bronchoscopic Bronchoalveolar Lavage Catheter
Device class
Class 1
Regulation
21 CFR 868.6810
Advisory panel
Anesthesiology
Total cleared
1
First cleared
Most recent

FDA classification definition

“To perform non-bronchoscopic bronchoalveolar lavage (bal) in adult patients undergoing mechanical ventilation.”

— U.S. Food and Drug Administration, device classification record for product code OYI under 21 CFR 868.6810, via openFDA

Market context for product code OYI

FDA has cleared 1 device under product code OYI, all in 2011, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code OYI

Recent clearances under product code OYI

Data sourced from openFDA. This site is unofficial and independent of the FDA.