DeviceClearance

Product code OBI— Cardiovascular

ACIST RXi System and Navvus II Catheter

Classification name
Catheter, Pressure Monitoring, Cardiac
Device class
Class 2
Regulation
21 CFR 870.1200
Advisory panel
Cardiovascular
Total cleared
1
First cleared
Most recent

FDA classification definition

“To measure pressure within the cardiovascular system.”

— U.S. Food and Drug Administration, device classification record for product code OBI under 21 CFR 870.1200, via openFDA

Market context for product code OBI

FDA has cleared 1 device under product code OBI, all in 2019, 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.

Top applicants under product code OBI

Recent clearances under product code OBI

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