OBI · Class II · 21 CFR 870.1200

FDA Product Code OBI: Catheter, Pressure Monitoring, Cardiac

To Measure Pressure Within The Cardiovascular System.

Leading manufacturers include Acist Medical Systems, Inc..

1
Total
1
Cleared
198d
Avg days
2019
Since

FDA 510(k) Cleared Catheter, Pressure Monitoring, Cardiac Devices (Product Code OBI)

1 devices
1–1 of 1
Cleared Sep 13, 2019
ACIST RXi System and Navvus II Catheter
K190473
Acist Medical Systems, Inc.
Cardiovascular · 198d

About Product Code OBI - Regulatory Context