DeviceClearance

Product code QFJ— Cardiovascular

Early Bird Bleed Monitoring System

Classification name
Intravascular Bleed Monitor
Device class
Class 2
Regulation
21 CFR 870.1345
Advisory panel
Cardiovascular
Total cleared
2
First cleared
Most recent

FDA classification definition

“An intravascular bleed monitor is a probe, catheter, or catheter introducer that measures changes in bioimpedance and uses an algorithm to detect or monitor progression of potential internal bleeding complications.”

— U.S. Food and Drug Administration, device classification record for product code QFJ under 21 CFR 870.1345, via openFDA

Market context for product code QFJ

FDA has cleared 2 devices under product code QFJ between 2019 and 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QFJ

Recent clearances under product code QFJ

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