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 K032884
Device Name FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH
Applicant
Boston Scientific Epi
2525 Walsh Ave.
Santa Clara,  CA  95051
Applicant Contact DEBBIE MCINTIRE
Correspondent
Boston Scientific Epi
2525 Walsh Ave.
Santa Clara,  CA  95051
Correspondent Contact DEBBIE MCINTIRE
Regulation Number870.1250
Classification Product Code
NFA  
Date Received09/16/2003
Decision Date 08/06/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-