Product code OWQ

Device name

Reprocessed Intravascular Ultrasound Catheter

Medical specialty

Cardiovascular

Device class

2

Regulation number

870.1200

Review panel

CV

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.

Source

FDA openFDA device classification dataset