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510(k) K123605

Device
SMARTFLOW CATHETER
Applicant
MRI INTERVENTIONS, INC.
510(k) number
K123605
Product code
HCA  
Decision
Substantially Equivalent (SESE)
Decision date
2013-08-16
Date received
2012-11-21
Regulation
882.4100
Classification name
Catheter, Ventricular
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
EDWARD F WADDELL
Address
5 Musick Irvine CA US 92618 92618

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HCA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K161731Cleveland Multiport Ventricular Catheter SetParker Hannifin Corp.2017-03-27
K031123CODMAN BACTISEAL BARIUM STRIPED CATHETERSCodman & Shurtleff, Inc.2003-05-14
K021481BRESAGEN CATHETER, MODEL CS-3000Bresagen, Inc.2002-08-06
K020728MIETHKE SHUNT SYSTEMAesculap, Inc.2002-04-05
K013005ACT 11 MP VENTRICULAR CATHETERInnerspace, Inc.2002-03-08
K003322CODMAN BACTISEAL CATHETERSCodman & Shurtleff, Inc.2001-10-01
K992796ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000Image-Guided Neurologics, Inc.1999-10-25
K983331MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102Medtronic PS Medical1998-12-16
K834477DISPOS. SCOTT CANNULAS 16-1054 ETC.Codman & Shurtleff, Inc.1984-03-19

Legacy Summary#

summary

FDA Review#

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