OBI — Catheter, Pressure Monitoring, Cardiac Class II

FDA Device Classification

Classification Details

Product Code
OBI
Device Class
Class II
Regulation Number
870.1200
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Definition

To measure pressure within the cardiovascular system.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K190473acist medical systemsACIST RXi System and Navvus II CatheterSeptember 13, 2019