• 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
LeMaitre Vascular
63 Second Avenue
burlington,  MA  01803
Applicant Contact john n. bradsher
LeMaitre Vascular
63 Second Avenue
burlington,  MA  01803
Correspondent Contact john n. bradsher
Regulation Number870.4885
Classification Product Code
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