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 catheter, angioplasty, peripheral, transluminal
510(k) Number K060959
Device Name SYMMETRY BALLOON DILATATION CATHETER
Applicant
Boston Scientific Corporation
TWO SCIMED PLACE
MAPLE GROVE,  MN  55311
Applicant Contact ANGELA BYLAND
Correspondent
Boston Scientific Corporation
TWO SCIMED PLACE
MAPLE GROVE,  MN  55311
Correspondent Contact ANGELA BYLAND
Regulation Number870.1250
Classification Product Code
LIT  
Date Received04/07/2006
Decision Date 04/12/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-