FDA 510(k) Applications for Medical Device Product Code "HCA"
(Catheter, Ventricular)

FDA 510(k) Number Applicant Device Name Decision Date
K020728 AESCULAP, INC. MIETHKE SHUNT SYSTEM 04/05/2002
K021481 BRESAGEN, INC. BRESAGEN CATHETER, MODEL CS-3000 08/06/2002
K031123 Codman & Shurtleff, Inc. CODMAN BACTISEAL BARIUM STRIPED CATHETERS 05/14/2003
K003322 Codman & Shurtleff, Inc. CODMAN BACTISEAL CATHETERS 10/01/2001
K834477 CODMAN & SHURTLEFF, INC. DISPOS. SCOTT CANNULAS 16-1054 ETC. 03/19/1984
K992796 IMAGE-GUIDED NEUROLOGICS, INC. ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000 10/25/1999
K013005 INNERSPACE, INC. ACT 11 MP VENTRICULAR CATHETER 03/08/2002
K983331 MEDTRONIC PS MEDICAL MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102 12/16/1998
K123605 MRI INTERVENTIONS, INC. SMARTFLOW CATHETER 08/16/2013
K161731 Parker Hannifin Corp. Cleveland Multiport Ventricular Catheter Set 03/27/2017


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