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 Graft, Vascular, Synthetic/Biologic Composite
510(k) Number K103080
Device Name ALBOGRAFT VASCULAR PROSTHESIS
Applicant
LEMAITRE VASCULAR, INC.
63 2ND AVENUE
BURLINGTON,  MA  01803
Applicant Contact ANDREW HODGKINSON
Correspondent
LEMAITRE VASCULAR, INC.
63 2ND AVENUE
BURLINGTON,  MA  01803
Correspondent Contact ANDREW HODGKINSON
Regulation Number870.3450
Classification Product Code
MAL  
Date Received10/19/2010
Decision Date 01/19/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-