510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K011812Substantially Equivalent

Spectrum Ventricular Catheter

Cook Inc., Bloomington IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011812 is the FDA 510(k) clearance record for SPECTRUM VENTRICULAR CATHETER, a class II device, cleared for Cook, Inc. on under FDA product code NHC (Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)). FDA's definition for product code NHC reads: "Used to gain access to the cavities of the brain for injection of material into or removal of material from the brain". FDA records list 163 510(k) clearances for Cook, Inc., from to . As of , FDA records show one recall naming K011812.

Clearance record

Decision date
Received
(150 days to decision)
Product code
NHC Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)
Regulation
21 CFR 882.4100
Device class
Class II
Review panel
Neurology
Applicant
Cook, Inc. 925 S. Curry Pike, Bloomington IN
510(k) summary
Summary
Third party review
No

Clearances, product code NHC

Trailing 12 months

FDA records hold no clearances under product code NHC in the trailing twelve months.

FDA records show no clearances under product code NHC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NHC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260