HCA · Class II · 21 CFR 882.4100

FDA Product Code HCA: Catheter, Ventricular

Leading manufacturers include Codman & Shurtleff, Inc., Innerspace, Inc. and Aesculap, Inc..

10
Total
10
Cleared
147d
Avg days
1984
Since

FDA 510(k) Cleared Catheter, Ventricular Devices (Product Code HCA)

10 devices
1–10 of 10
Cleared Mar 27, 2017
Cleveland Multiport Ventricular Catheter Set
K161731
Parker Hannifin Corp.
Neurology · 277d
Cleared Aug 16, 2013
SMARTFLOW CATHETER
K123605
Mri Interventions, Inc.
Neurology · 268d
Cleared May 14, 2003
CODMAN BACTISEAL BARIUM STRIPED CATHETERS
K031123
Codman & Shurtleff, Inc.
Neurology · 35d
Cleared Aug 06, 2002
BRESAGEN CATHETER, MODEL CS-3000
K021481
Bresagen, Inc.
Neurology · 90d
Cleared Apr 05, 2002
MIETHKE SHUNT SYSTEM
K020728
Aesculap, Inc.
Neurology · 30d
Cleared Mar 08, 2002
ACT 11 MP VENTRICULAR CATHETER
K013005
Innerspace, Inc.
Neurology · 183d
Cleared Oct 01, 2001
CODMAN BACTISEAL CATHETERS
K003322
Codman & Shurtleff, Inc.
Neurology · 342d
Cleared Oct 25, 1999
ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000
K992796
Image-Guided Neurologics, Inc.
Neurology · 67d
Cleared Dec 16, 1998
MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102
K983331
Medtronic PS Medical
Neurology · 85d
Cleared Mar 19, 1984
DISPOS. SCOTT CANNULAS 16-1054 ETC.
K834477
Codman & Shurtleff, Inc.
Neurology · 90d

About Product Code HCA - Regulatory Context