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) | Registration & Listing | Adverse Events | Recalls | PMA | 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, intravascular, diagnostic
510(K) Number K040776
Device Name ATLANTIS SR, MODEL C4020; ATLANTIS SR PLUS, MODEL 35975
Applicant
BOSTON SCIENTIFIC CORP.
47900 bayside parkway
fremont,  CA  94538 6515
Contact robert z phillips
Regulation Number870.1200
Classification Product Code
DQO  
Date Received04/02/2004
Decision Date 04/29/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
statement statement
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-