510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K854474Substantially Equivalent

External Ventricular Drainage/monitoring/lumbar Se

Cordis US Corp., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854474 is the FDA 510(k) clearance record for EXTERNAL VENTRICULAR DRAINAGE/MONITORING/LUMBAR SE, a class II device, cleared for Cordis Corp. on under FDA product code JXG (Shunt, Central Nervous System And Components). FDA records list 332 510(k) clearances for Cordis US Corp., from to . As of , FDA records show no recalls naming K854474.

Clearance record

Decision date
Received
(20 days to decision)
Product code
JXG Shunt, Central Nervous System And Components
Regulation
21 CFR 882.5550
Device class
Class II
Review panel
Neurology
Applicant
Cordis Corp. P.O. Box 025700, Miami FL
Third party review
No

Clearances, product code JXG

Trailing 12 months
5 clearances under product code JXG in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code JXG, trailing twelve months
MonthClearances
November 20252
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20261