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 K153502
Device Name ClariVein IC
Applicant
Vascular Insights, LLC
1 Pine Hill Dr., Two Batterymarch Park, Suite 100
Quincy,  MA  02169
Applicant Contact LORRAINE M. HANLEY
Correspondent
Vascular Insights, LLC
1 Pine Hill Dr., Two Batterymarch Park, Suite 100
Quincy,  MA  02169
Correspondent Contact LORRAINE M. HANLEY
Regulation Number870.1210
Classification Product Code
KRA  
Date Received12/07/2015
Decision Date 01/06/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-