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 temporary carotid catheter for embolic capture
510(k) Number K082348
Device Name FIBERNET EMBOLIC PROTECTION SYSTEM
Applicant
LUMEN BIOMEDICAL, INC.
14505 21ST AVE. NORTH
SUITE 212
PLYMOUTH,  MN  55447
Applicant Contact MARIA E BRITTLE
Correspondent
LUMEN BIOMEDICAL, INC.
14505 21ST AVE. NORTH
SUITE 212
PLYMOUTH,  MN  55447
Correspondent Contact MARIA E BRITTLE
Regulation Number870.1250
Classification Product Code
NTE  
Date Received08/15/2008
Decision Date 11/18/2008
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
-
-