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, Intravascular, Diagnostic
510(k) Number K050577
Device Name ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014
Applicant
Boston Scientific Corp
47201 Lakeview Blvd.
Fremont,  CA  94537
Applicant Contact VERONICA M KOCKEN
Correspondent
Boston Scientific Corp
47201 Lakeview Blvd.
Fremont,  CA  94537
Correspondent Contact VERONICA M KOCKEN
Regulation Number870.1200
Classification Product Code
DQO  
Date Received03/07/2005
Decision Date 03/30/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-