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 Valvulotome
510(k) Number K190267
Device Name EZE SIT Valvulotome
Applicant
Lemaitre Vascular
63 Second Ave.
Burlington,  MA  01803
Applicant Contact John N. Bradsher
Correspondent
Lemaitre Vascular
63 Second Ave.
Burlington,  MA  01803
Correspondent Contact John N. Bradsher
Regulation Number870.4885
Classification Product Code
MGZ  
Date Received02/08/2019
Decision Date 10/30/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-