Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Catheter, Ventricular
510(k) Number K123605
Device Name SMARTFLOW CATHETER
Applicant
Mri Interventions, Inc.
5 Musick
Irvine,  CA  92618
Applicant Contact EDWARD F WADDELL
Correspondent
Mri Interventions, Inc.
5 Musick
Irvine,  CA  92618
Correspondent Contact EDWARD F WADDELL
Regulation Number882.4100
Classification Product Code
HCA  
Date Received11/21/2012
Decision Date 08/16/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-