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
K854657Substantially Equivalent

Intracranial Pressure Monitoring Cup Catheters

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

K854657 is the FDA 510(k) clearance record for INTRACRANIAL PRESSURE MONITORING CUP CATHETERS, a class II device, cleared for Cordis Corp. on under FDA product code GWM (Device, Monitoring, Intracranial Pressure). FDA records list 332 510(k) clearances for Cordis US Corp., from to . As of , FDA records show no recalls naming K854657.

Clearance record

Decision date
Received
(37 days to decision)
Product code
GWM Device, Monitoring, Intracranial Pressure
Regulation
21 CFR 882.1620
Device class
Class II
Review panel
Neurology
Applicant
Cordis Corp. P.O. Box 025700, Miami FL
Third party review
No

Clearances, product code GWM

Trailing 12 months
1 clearance under product code GWM in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GWM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260