DeviceClearance

Product code NHC— Neurology

SPECTRUM VENTRICULAR CATHETER

Classification name
Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)
Device class
Class 2
Regulation
21 CFR 882.4100
Advisory panel
Neurology
Total cleared
3
First cleared
Most recent

FDA classification definition

“Used to gain access to the cavities of the brain for injection of material into or removal of material from the brain.”

— U.S. Food and Drug Administration, device classification record for product code NHC under 21 CFR 882.4100, via openFDA

Market context for product code NHC

FDA has cleared 3 devices under product code NHC between 2001 and 2016, filed by 2 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 NHC

Recent clearances under product code NHC

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