DeviceClearance

Product code BTC— Anesthesiology

BREATHING BAGS

Classification name
Bag, Reservoir
Device class
Class 1
Regulation
21 CFR 868.5320
Advisory panel
Anesthesiology
Total cleared
19
First cleared
Most recent

Market context for product code BTC

FDA has cleared 19 devices under product code BTC between 1979 and 2018, filed by 18 applicant companies. 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.

Clearances per year

Top applicants under product code BTC

Recent clearances under product code BTC

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