Product code QFJ

Device name

Intravascular Bleed Monitor

Medical specialty

Cardiovascular

Device class

2

Regulation number

870.1345

Review panel

CV

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset