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 K946352
Device Name LEMAITRE VALVULOTOME II
Applicant
Vascutech, Inc.
790 Tpke. St.
North Andover,  MA  01845
Applicant Contact GEORGE W LEMAITRE
Correspondent
Vascutech, Inc.
790 Tpke. St.
North Andover,  MA  01845
Correspondent Contact GEORGE W LEMAITRE
Regulation Number870.4885
Classification Product Code
MGZ  
Date Received12/30/1994
Decision Date 06/21/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-