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, percutaneous
510(k) Number K142449
Device Name Headway 27 Microcatheter
Applicant
MICRO VENTION, INC.
1311 VALENCIA AVENUE
TUSTIN,  CA  92780
Applicant Contact Cynthia Valenzuela
Correspondent
MICRO VENTION, INC.
1311 VALENCIA AVENUE
TUSTIN,  CA  92780
Correspondent Contact Cynthia Valenzuela
Regulation Number870.1250
Classification Product Code
DQY  
Date Received09/02/2014
Decision Date 03/26/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-