DeviceClearance

Product code PNE— Cardiovascular

Reprocessed Agilis NxT Steerable Introducer

Classification name
Reprocessed Catheter Introducer
Device class
Class 2
Regulation
21 CFR 870.1340
Advisory panel
Cardiovascular
Total cleared
7
First cleared
Most recent

FDA classification definition

“Introduce various cardiovascular catheters into the heart and cardiovascular system”

— U.S. Food and Drug Administration, device classification record for product code PNE under 21 CFR 870.1340, via openFDA

Market context for product code PNE

FDA has cleared 7 devices under product code PNE between 2016 and 2026, filed by 4 applicant companies. 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.

Clearances per year

Top applicants under product code PNE

Recent clearances under product code PNE

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