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 coronary saphenous vein bypass graft for embolic protection
510(k) Number K061332
Device Name FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM)
Applicant
BOSTON SCIENTIFIC CORP.
2011 STIERLIN CT.
MOUNTAIN VIEW,  CA  94043 -4655
Applicant Contact DEBBIE MCINTIRE
Correspondent
BOSTON SCIENTIFIC CORP.
2011 STIERLIN CT.
MOUNTAIN VIEW,  CA  94043 -4655
Correspondent Contact DEBBIE MCINTIRE
Regulation Number870.1250
Classification Product Code
NFA  
Date Received05/12/2006
Decision Date 08/11/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-