DeviceClearance

Product code NPG— Cardiovascular

Stratus Infusion Catheter

Classification name
Catheter, Infusion, Syringe
Device class
Class 2
Regulation
21 CFR 870.1210
Advisory panel
Cardiovascular
Total cleared
1
First cleared
Most recent

FDA classification definition

“To provide physician specified fluids both perivascular or intraluminal to the perivascular space.”

— U.S. Food and Drug Administration, device classification record for product code NPG under 21 CFR 870.1210, via openFDA

Market context for product code NPG

FDA has cleared 1 device under product code NPG, all in 2023, 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 NPG

Recent clearances under product code NPG

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