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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name stripper, artery, intraluminal
510(K) Number K121415
Model 4500
Device Name MOLLRING MULTITASC
Applicant
LEMAITRE VASCULAR, INC.
63 2nd avenue
bedford,  MA  01803
Contact andrew hodgkinson
Regulation Number870.4875
Classification Product Code
DWX  
Date Received05/11/2012
Decision Date 09/05/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-