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, Continuous Flush
510(k) Number K113289
Device Name ORION MICRO CATHETER
Applicant
MICRO THERAPEUTICS, INC.
9775 TOLEDO WAY
IRVINE,  CA  92618
Applicant Contact ANALIA NIETO
Correspondent
MICRO THERAPEUTICS, INC.
9775 TOLEDO WAY
IRVINE,  CA  92618
Correspondent Contact ANALIA NIETO
Regulation Number870.1210
Classification Product Code
KRA  
Date Received11/07/2011
Decision Date 08/01/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-